Silicon Investor - dsco Discovery Laboratories

[Arthur Radley] Touching article about premature births and the use of surfactants. today.com

Arthur Radley — 12/1/2013 3:00:42 PM

[semi_infinite ] You can bet the rest of the syndicate will follow through with something positiv...

semi_infinite — 11/12/2013 9:42:30 PM

You can bet the rest of the syndicate will follow through with something positive to say. Par for the course.

[Arthur Radley] Piper Jaffray coverage on shares of Discovery Laboratories with an “overweight” ...

Arthur Radley — 11/11/2013 9:04:15 AM

Piper Jaffray coverage on shares of Discovery Laboratories with an “overweight” (6.00 price)
Piper Jaffray initiated coverage on shares of Discovery Laboratories (NASDAQ: DSCO) with an “overweight” rating. The target price for Discovery Laboratories is set to $6. Discovery's shares closed at $2.01 on Friday.

I would settle for $5.00--nice bounce in pre-market this morning.

[semi_infinite ] I will continue to nibble down here. Stock won't move till we get positive sale...

semi_infinite — 11/8/2013 9:57:53 AM

I will continue to nibble down here. Stock won't move till we get positive sales data.

[Arthur Radley] Finally got the product launch announcement this morning--now lets see some impr...

Arthur Radley — 11/8/2013 9:26:27 AM

Finally got the product launch announcement this morning--now lets see some improvement in the stock price.

[Arthur Radley] Semi, I hate seeing a secondary offering for stocks I hold, however, for the DSC...

Arthur Radley — 10/31/2013 5:42:51 PM

Semi,
I hate seeing a secondary offering for stocks I hold, however, for the DSCO deal I think there is some merit to their timing. The key for their long-term success is expanding the market with their Aerosurf product. Therefore, it's key that they move forward with this program ASAP. DSCO has the draw down loan situation that would have given them limited funding, but there is a great downside to these 'loan' deals, whereas, the secondary is a straight forward deal.

My thinking is this and the underwriters probably put some pressure on them to get the deal done now--and the number and actual underwriters is a good sign that the market would take the stock. Basically, the floor for the stock is the $2.00 deal, and with any good launch news in the next few weeks, should give us a nice bounce. Some might say that doing the deal before the actual launch is a bad sign..........but I think differently. Within the next few weeks--actual launch of Surfaxin, and I think some news on Afectair sales. IMO, DSCO has been marketing Afectair for nearly a year with actual deals tied to Surfaxin. "IF" and big if-- a big deal could be announced as for a major neonatal hospital having adopted the combined product that would be a nice catalyst. Also, there is the chance that we could hear something from the European market in the short term.

For what its worth---I actually bought more shares this morning at net total of $2.02. Was nice to see that the stock close with a nice bounce from the $2.00 secondary. My entry price for the stock is well below $2.00--so IMO now would be a good time to take a position---with fingers crossed that the launch goes well. They sure have had the time to pre-market the product.

Good luck!

[semi_infinite ] It is safer to enter the water now post dilution. However, It is only a trade u...

semi_infinite — 10/31/2013 5:19:43 PM

It is safer to enter the water now post dilution. However, It is only a trade until they prove that they can get their act together commercially. Their track record does not engender confidence.

[Arthur Radley] Semi, I think that number is in the ball park for cost treating these prematu...

Arthur Radley — 10/18/2013 12:17:20 PM

Semi,

I think that number is in the ball park for cost treating these premature babies. I think management has done a good job of collecting data before the launch that validates the drug has shown that hospital stays have been cut when compared to current treatment methods. The goal is getting the baby out of ICU, so the drug that does this will garner wider acceptance by the hospitals. If I were making the decision, I would suggest that DSCO price the drug very competitively against the current drugs. My rational is that this market is limited, thus it will never be the product that makes DSCO that $1 billion dollar revenue company. I believe in the current expansion that DSCO is taking this product with the just announced plans for the Phase II trial. Hospitals don’t like to carry different drugs for the same treatment like the premature babies, etc. DSCO by making their drug not only cost competitive but also more efficacies could speed up hospital acceptance and have them locked into place when the expanded usage is proven for the new formulation.

http://www.ncbi.nlm.nih.gov/books/NBK11358/#a20012272ddd00317

[semi_infinite ] Are they realistic with pricing? They used $8000/course to estimate market pote...

semi_infinite — 10/18/2013 11:42:59 AM

Are they realistic with pricing? They used $8000/course to estimate market potential.

[Arthur Radley] Fred, I agree with you about the presentation! One of the better presentations t...

Arthur Radley — 10/17/2013 11:06:22 AM

Fred,
I agree with you about the presentation! One of the better presentations that I've heard. No hype! The presenter about the trial was excellent---very fluid presentation and not jazzed up with medical jargon that the lay person couldn't understand. They were very realistic in plans--liked it when the questioner wanted to know if they could file NDA based on Phase II data. Response was very conservative and steered away from saying this was the possibility. At least it appears this new group has learned from over promising in the past. If I understood, they will enroll about 60 babies and the Phase II data will be available around mid-2014.

I think we have built a nice floor under the stock--and now should see a gradual rise to at least the $3.00 as we wait for this initial Phase II data. Also, I would expect to see a bump when they announce the official launch and maybe the first PO--around Thanksgiving.

Good luck!
Cary

[fred hayes] Highly recommend today's presentation. Very simple case, even I can understand ...

fred hayes — 10/17/2013 10:57:07 AM

Highly recommend today's presentation. Very simple case, even I can understand it. Hope nothing unexpected turns up with the aerosol delivery. This looks like major advance for babies, which I think is very cool...

[Arthur Radley] I'm surprised with the news today--filing for the IND came quicker than I though...

Arthur Radley — 10/17/2013 9:45:25 AM

I'm surprised with the news today--filing for the IND came quicker than I thought. Apparently they haven't been sitting around all this time. The key for this company is expanding the indications for their platform---finally we might be getting somewhere after all these years of hoping and waiting--

WARRINGTON, Pa., Oct. 17, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. ( DSCO), a specialty biotechnology company dedicated to advancing a new standard of respiratory critical care, today announced that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate its AEROSURF® phase 2 clinical program. The FDA has confirmed receipt of the IND and has indicated that, unless otherwise notified during its review, the Company may initiate the phase 2 clinical program after a 30-day period. Discovery Labs anticipates patient enrollment could begin in the fourth quarter of 2013. The Company will host a conference call this morning at 10:00 AM ET to discuss the AEROSURF program. Conference call details are below.

"The filing of our AEROSURF IND with the FDA represents an important milestone for our Company and a first step towards a potentially transformational medical advancement for the neonatology community and the infants they care for," said John G. Cooper, Chief Executive Officer at Discovery Labs.

[fred hayes] Approved.

fred hayes — 10/4/2013 8:41:48 AM

[ewolf] Maybe this stems from the fact that dsco is making a conference appearance. Spec...

ewolf — 9/6/2013 3:44:27 PM

Maybe this stems from the fact that dsco is making a conference appearance. Speculation seems to be the rule these day. Hope it's news. Beyond a slog.

[Arthur Radley] Something is cooking in the kitchen and I don't think it's Diana! Stock volume i...

Arthur Radley — 9/6/2013 9:59:32 AM

Something is cooking in the kitchen and I don't think it's Diana! Stock volume in first 30 minutes has exceeded daily normal for shares traded. Also, if currently level holds this would take us back to April 5th, when the stock fell off the tracks with the delay announcement. Maybe!!!! What a slog.

[Arthur Radley] Sudden pop in volume and stock moved up by 6%--several large blocks traded--What...

Arthur Radley — 6/18/2013 12:44:58 PM

Sudden pop in volume and stock moved up by 6%--several large blocks traded--Whats UP?

[Arthur Radley] I sold all my shares today-----------and in A-H we get this news. I told the ma...

Arthur Radley — 4/15/2013 5:59:58 PM

I sold all my shares today-----------and in A-H we get this news. I told the management at last year's shareholder meeting that they didn't have a clue as for running a company. Now the insider are even throwing in the towel.

5:42 PM Discovery Labs ( DSCO) files a registration with the SEC to sell up to 2.34M shares of on behalf of selling shareholders. The company will not receive proceeds from the secondary offering.

[Arthur Radley] seekingalpha.com Maybe one day---but it finally is looking more encouraging for...

Arthur Radley — 3/21/2013 5:56:55 PM

seekingalpha.com

Maybe one day---but it finally is looking more encouraging for them making it!!! Has been a long slog!

[fred hayes] Thanks, knew they would need cash. This looks better than it might have been, g...

fred hayes — 2/14/2013 7:02:08 PM

Thanks, knew they would need cash. This looks better than it might have been, guess that's what has moved the stock...

[tuck] >>13-Feb-2013 Entry into a Material Definitive Agreement, Creation of a Direct ...

tuck — 2/14/2013 3:17:05 PM

>>13-Feb-2013

Entry into a Material Definitive Agreement, Creation of a Direct

Item 1.01 Entry into a Material Definitive Agreement. Loan Facility with Deerfield Management Company, L.P.

Facility Agreement

On February 13, 2013, Discovery Laboratories, Inc. (the "Company") entered into a Facility Agreement (the "Facility Agreement") with affiliates of Deerfield Management Company, L.P. ("Deerfield"), pursuant to which Deerfield agreed to provide financing to the Company of up to $30 million on a secured basis, subject to the terms and conditions set forth in the Facility Agreement (the "Financing"). Under the terms of the Facility Agreement, Deerfield shall advance funds to the Company in two disbursements. The first disbursement, in the amount of $10 million occurred upon execution of the Facility Agreement (the "Agreement Date"). The second disbursement, in the amount of $20 million, will occur on or about the date of the first commercial sale of SURFAXIN? (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS, provided that such initial product sale date is not later than December 31, 2013 (the "Milestone Date"). The Company is required to pay to Deerfield at the time of each disbursement a transaction fee equal to one and one-half percent (1.5%) of the amount disbursed under the Facility Agreement.

Any amounts drawn under the Facility Agreement shall accrue interest at a rate of 8.75% per annum, which shall be payable quarterly in cash. The Company has the right to prepay any amounts owed without penalty. In addition, at the election of the holders of the notes evidencing loans under the Facility Agreement ("Notes"), the principal amounts of the Notes may be reduced to the extent that the holders elect to apply a portion of the principal amount outstanding under the Notes to satisfy the exercise price of the related Warrants (see below) upon exercise of all or a portion of the Warrants. The principal amounts outstanding under the Facility Agreement are payable in equal installments on the fourth, fifth and sixth anniversaries of the Facility Agreement; provided that the amount payable on the fourth anniversary shall be deferred for one year if either (i) the Company's "Net Sales" (defined below) for the immediately preceding 12-month period are at least $20 million, or (ii) the Company's "Equity Value" (defined below) is at least $200 million; and provided further, that the amount payable on the fifth anniversary (together with any amount deferred on the fourth anniversary) shall be deferred until the sixth anniversary if either (x) the Company's "Net Sales" for the immediately preceding 12 month period are at least $30 million, or (ii) the Company's "Equity Value" is at least $250 million. For the purposes of the foregoing deferrals of principal, "Net Sales" means, without duplication, the gross amount invoiced by or on behalf of the Company, any of its Subsidiaries or any direct or indirect assignee or licensee for products, sold globally in bona fide, arm's length transactions, less customary deductions determined without duplication in accordance with generally accepted accounting principles; and "Equity Value" means, with respect to each measurement date, the product of (x) the number of issued and outstanding shares of common stock of the Company (the "Common Stock") on such measurement date multiplied by (y) the per share closing price of the Common Stock on such measurement date.

Additionally, any amounts drawn under the Facility Agreement may become immediately due and payable upon (i) an "Event of Default," as defined in the Facility Agreement, in which case Deerfield would have the right to require the Company to repay the outstanding principal amount of the loan, plus any accrued and unpaid interest thereon, or (ii) the occurrence of certain events as defined in the Facility Agreement, including the consummation of a change of control transaction or the sale of more than 50% of the Company's assets (collectively, a "Major Transaction").

The Facility Agreement also contains various representations and warranties and affirmative and negative covenants customary for financings of this type, including restrictions on the ability of the Company to incur additional indebtedness and grant additional liens on its assets.

Warrants

In connection with the execution of the Facility Agreement, on February 13, 2013, the Company issued to Deerfield warrants to purchase an aggregate of 2,340,000 shares of the Common Stock at an exercise price of $2.81 per share of Common Stock, representing a 24% premium to the closing price of Common Stock on the Nasdaq Capital Market on the immediately preceding trading day. Following the Milestone Date and upon disbursement of the additional $20 million loan under the Facility Agreement, the Company will issue warrants to purchase an additional 4,660,000 shares of Common Stock at an exercise price of $2.81 per share of Common Stock (together with the warrants in the preceding sentence, the "Warrants"). The number of shares of Common Stock into which a Warrant is exercisable and the exercise price of any Warrant will be adjusted to reflect any stock splits, recapitalizations or similar adjustments in the number of outstanding shares of Common Stock.

Each Warrant issued under the Facility Agreement expires on the sixth anniversary of the Facility Agreement and contains certain limitations that generally prevent the holder from acquiring shares upon exercise of a Warrant that would result in the number of shares beneficially owned by it to exceed 9.985% of the total number of shares of Common Stock then issued and outstanding.

The holder of a Warrant may exercise the Warrants either for cash or on a cashless basis. In connection with a Major Transaction, as defined in the Warrants, to the extent of consideration payable to stockholders in cash in connection with such Major Transaction, the holder may have the option to redeem the Warrant or that portion of the Warrant for cash in an amount equal to the Black-Scholes value (as defined in the Warrant) of the Warrant or that portion of the Warrant redeemed. In addition, in connection with a Major Transaction, to the extent of any consideration payable to stockholders in securities, or in the event of an Event of Default, the holder may have the option to exercise the Warrant and receive therefor that number of shares of Common Stock that equals the Black Scholes value of the Warrant or that portion of the Warrant exercised. Prior to the holder exercising the Warrant for shares in such transactions, the Company may elect to terminate the Warrant or that portion of the Warrant and pay the holder cash in an amount equal to the Black Scholes value of the Warrant.<<

Somewhat better terms than previous arrangements. Last I saw, DSCO was guiding for a 2nd quarter launch, so let's hope they're not off by too much!

Cheers, Tuck

[fred hayes] Thanks for the detailed report, much appreciated. I still think the stock is si...

fred hayes — 9/17/2012 9:41:42 PM

Thanks for the detailed report, much appreciated. I still think the stock is silly-cheap, but I have been consistently wrong on this company.

[Arthur Radley] The following points are strictly my opinion, but based on attending the meeting...

Arthur Radley — 9/17/2012 5:20:37 PM

The following points are strictly my opinion, but based on attending the meeting and talking with executives.
1) Company execs are enthused about the product and think they have a game changer as for current and future applications for their drug and delivery system.
2) 20 member sales team is in place and currently being taken through training program.
3) One unique aspect of the meeting was that prior to starting a lady approached Mr. Amick and asked if he knew who she was. He admitted that he didn't recognize her. Turns out she was the co-discoverer of Surfaxin. Amick graciously recognized her to the attendees at the start of the meeting.(Nice touch)
4) For those who think that the stock is going to 'sky-rocket-to-the-moon'--think again! We investors are in for a long slog. The market they are going to initially compete for is only worth $75M.
5) Based on Abbott's drug cost, DSCO is going to take an approach that is in my opinion, fraught with some strong head winds. They are going to approach hospitals with the premise that they deserve a premium price because of the usual--safer because non-animal based product. The new approach will be based on efficacy and safety due to issue of re-intubation of fragile patients.(This issue is real, however, hospitals are currently operating on tight budget constraints.) Sales force knowledge of product and issues will be critical. Holding off launch and training to this point has been a good approach. In private conversation I conveyed to Tom Miller, that DSCO has done an excellent job in pre-marketing campaign. There will be some off-lable uses, due to these efforts.(IMO)
6) My main issue is the fact that they are only looking for partnership deals with foreign entities. My issue and I openly broached it with them is that time is of the essence. Delaying Phase testing for expanded indications for this drug is critical--relying on revenue from $75million dollar market isn't going to give them the money they need. Delaying until late 2013 for new trials.........bad decision, IMO.
7)They listened to my concerns and gave a robust rebuttal. Time will tell! But with the history, DSCO needs a solid game plan with no missteps. I enjoyed my private conversation with Tom Miller--a bright young man and very passionate in his beliefs about the company.
8) They need female representation in the executive ranks of the company.
I suggest one hold their position in the stock, we might and should get a small bounce from launch. But head winds are going to be blowing until we get expanded indications for the product.

Sentiment: Hold

[fred hayes] Very cool. Let us know if anything of note comes up. I think dsco is silly che...

fred hayes — 9/12/2012 9:45:47 PM

Very cool. Let us know if anything of note comes up. I think dsco is silly cheap, but I have said that before and turned out to be wrong. Now that surfaxin is approved, I just don't understand how the docs could use anything else (once it is launched). And looks to me like lots of room to increase the price above the animal derived stuff.

fred

[Arthur Radley] I plan to attend the annual meeting tomorrow--hope they have some news on partne...

Arthur Radley — 9/12/2012 7:42:28 PM

I plan to attend the annual meeting tomorrow--hope they have some news on partnership and launch schedule. The stock has performed nicely over the past few weeks--volume and upward movement today was excellent. This one has been a slog for many long term investors!

[Arthur Radley] More than a million shares traded in first 30 minutes today-stock back above $3....

Arthur Radley — 8/28/2012 10:09:12 AM

More than a million shares traded in first 30 minutes today-stock back above $3.00 with bump of more than 7% at this point. Off to the rodeo!

[Arthur Radley] Stifel Nicolaus Starts Discovery Laboratories (DSCO) at Buy7:07 AM ET, 08/24/...

Arthur Radley — 8/24/2012 9:14:15 AM

Stifel Nicolaus Starts Discovery Laboratories (DSCO) at Buy7:07 AM ET, 08/24/2012 - Street Insider
Stifel Nicolaus initiates coverage on Discovery Laboratories (NASDAQ: DSCO) with a Buy. PT $5.00.

For an analyst ratings summary and ratings history on Discovery Laboratories click here. For more ratings news on Discovery Laboratories click here.

Shares of Discovery Laboratories closed at $2.51 yesterday, with a 52 week range of $1.44-$5.39.

[Arthur Radley] Over recent months I've accumulated a nice position in this stock--average is ab...

Arthur Radley — 7/18/2012 8:49:34 AM

Over recent months I've accumulated a nice position in this stock--average is about $2.40--I bought a few shares yesterday, thinking that pending launch of the drug should give it a bump in price. I attempted to call the CFO yesterday to garner potential of when the product would be on the market.............he was business and unavailable..........Today's PR reveal maybe what he was doing. Anyone have an idea how this type product would serve this critical health area........

finance.yahoo.com

[fred hayes] Ya, I didn't think they would go for that much, and I thought the price would be...

fred hayes — 3/16/2012 9:46:38 AM

Ya, I didn't think they would go for that much, and I thought the price would be higher. Still, this looks silly cheap under $3. There isn't any doubt in my mind that Surfaxin will dominate the market. The animal derived stuff just shouldn't be used if I understand the situation correctly (always a dangerous proposition). And I don't think it will take very long. The docs are well aware of Surfaxin and the sad saga of getting this life saver to the market. Looks to me like you get aerosurf for free, and it could be huge...

[tuck] $2.80 for ~45 million. That really should hold them for a while. Message 28016...

tuck — 3/16/2012 9:40:34 AM

$2.80 for ~45 million. That really should hold them for a while.

Message 28016404

Cheers, Tuck

[dr.praveen] Looking at the 3m chart, it looks like sell on the news reaction. With it's mkt ...

dr.praveen — 3/15/2012 10:56:14 PM

Looking at the 3m chart, it looks like sell on the news reaction. With it's mkt cap, it looks attractive around the 3 area. lets wait for the no of shares and the pricing tomorrow morning. They should have given the pricing at the same time as offering inorder to avoid the knee jerk reaction. The money might also help if they are negotiating with a partner.

Even if surfaxin makes 40m/yr, not a bad trade though with the aerosurf's results in a yr's time.

[tuck] "They will be raising money soon." Check. This and uncertainty of market size ...

tuck — 3/15/2012 4:26:46 PM

"They will be raising money soon." Check.

This and uncertainty of market size as well as long time to market have capped the stock (oh, and maybe uncertainty regarding the company's ability to market the product).

So with the offering getting done (no details yet on the particulars), is this the next buying op? My understanding is Aerosurf results are over a year out. Methinks they need about $20 million over the next couple of years (this assumes a partnership of a few tens of millions). If this offering takes care of that -- or most of that -- and the stock takes the knee jerk hit (as it's starting to AH), it really could be a buying op, IMO.

Cheers, Tuck

[rkrw] Curosurf from CRTX has a run rate of about $35M per year, I think it's number 1 ...

rkrw — 3/6/2012 5:27:44 PM

Curosurf from CRTX has a run rate of about $35M per year, I think it's number 1 or 2 in market share.

If surfactants were first approved today, they'd price 20X higher or more.

Good New Yorker magazine article that mentions surfactant's.

newyorker.com

[tuck] Market for RDS: according the the Census Bureau there almost 4.3 million births...

tuck — 3/6/2012 5:21:23 PM

Market for RDS: according the the Census Bureau there almost 4.3 million births in the U.S. in 2008. This does not count births to non-residents.

http:///

And according to the American Thoracic Society, the RDS rate is 1%. So that would be ~43,000 annually. Would have to see if the label lowers that number any.

http:///

Cheers, Tuck

[Arthur Radley] Michael, The initial market for premature babies is fairly small--around 90,000...

Arthur Radley — 3/6/2012 5:17:52 PM

Michael,
The initial market for premature babies is fairly small--around 90,000 -100,000 yearly here in the US. However, when you factor in the full application for their technology--adults and other lung ailments that can be enhanced by their delivery system........we are talking big money. I think I remember that at one time DSCO projected a market of around $1B. Also, (IMO) this drug will not face the normal reluctance that doctors have in switching to another drug from what they have been utilizing.

Short term--we are probably looking at a stock offering to fund the launch. But also(IMO) they will be a prime candidate for a take out by one of the major pharmas. Again, without looking, I think they had a MC of under $100 million, so with a $1 Billion market potential............I ain't selling my shares until the dust settles.

[Michael Young] Any idea what this drug could be worth? MIKE

Michael Young — 3/6/2012 4:52:55 PM

[Arthur Radley] Your post got me thinking so I went back and found my first post about it on SI....

Arthur Radley — 3/6/2012 4:51:56 PM

Your post got me thinking so I went back and found my first post about it on SI.......the following is what I posted..................in 2001! 2001!

To: Cacaito who wrote (31)	7/13/2001 4:35:52 PM
From: Arthur Radley	Read Replies (1) of 282

I've owned this one for a while and the action today was great(wish there had been more volume), maybe with the start of the Phase III trial, this one is finally getting ready to make a run. One can hope! If Surfaxin works for IRDS and then if it could be utilized for pulmonary drug delivery.....Whoa!

[dr.praveen] Couple of things to add They will be raising money soon Aerosurf results will be...

dr.praveen — 3/6/2012 4:45:44 PM

Couple of things to add
They will be raising money soon
Aerosurf results will be int to watch

[FiloF] I bought my shares so long ago I have no idea how much I paid. I am sure I will...

FiloF — 3/6/2012 4:42:12 PM

I bought my shares so long ago I have no idea how much I paid. I am sure I will still be underwater. Have to go back to the archives...

[Arthur Radley] Talk about a long slog-----my daughter held this one through thick and then! Pri...

Arthur Radley — 3/6/2012 4:39:25 PM

Talk about a long slog-----my daughter held this one through thick and then! Prior management really screwed up what has all along proven to be a positive drug if only they could get the manufacturing process done right. I hope you had a few shares.

[dr.praveen] Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention ...

dr.praveen — 3/6/2012 4:18:45 PM

Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) for Prevention of Respiratory Distress SyndromeSURFAXIN is the First FDA-Approved Synthetic, Peptide-Containing Surfactant
Conference Call Tomorrow at 10 a.m. EST

WARRINGTON, Pa., March 6, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO - News), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the United States Food and Drug Administration (FDA) has approved SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Discovery Labs anticipates that SURFAXIN will be commercially available in the United States in late 2012.

"The approval of SURFAXIN is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS," said W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs. "This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care."

RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants.

PS: I own little as a flyer.Congrats... time to buy more in the next 6m cary:-)

[tuck] Surfaxin approved!!! Stock halted. Congrats to long suffering longs! Slight di...

tuck — 3/6/2012 4:14:42 PM

Surfaxin approved!!! Stock halted.

Congrats to long suffering longs!

Slight disappointment: not going to launch for ~6 months.

Edit: here's the PR now:

>>WARRINGTON, Pa., March 6, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO - News), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced that the United States Food and Drug Administration (FDA) has approved SURFAXIN (lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in premature infants at high risk for RDS. SURFAXIN is the first synthetic, peptide-containing surfactant approved for use in neonatal medicine. Discovery Labs anticipates that SURFAXIN will be commercially available in the United States in late 2012. "The approval of SURFAXIN is an important medical advancement for the neonatology community and parents of preterm infants who will soon have an effective alternative to animal-derived surfactants to prevent the development of RDS," said W. Thomas Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs. "This is a significant milestone in our continuing efforts to develop a pipeline of products to further advance the standard of respiratory critical care."

RDS is a condition in which premature infants are born with an insufficient amount of pulmonary surfactant, a substance produced naturally in the lungs and essential for breathing. Today, infants with RDS often require animal-derived surfactant replacement therapy along with mechanical ventilation to survive. Approximately 90,000 premature infants in the United States are treated annually with currently available animal-derived surfactants.

Discovery Labs will hold a conference call tomorrow, March 7th, 2012 at 10:00 a.m. EST to further discuss the foregoing. The call in number is (877) 215-0093. The international call in number is (706) 679-3237. The passcode is 58400332. This audio webcast will be available through a live broadcast on the Internet at us.meeting-stream.com and www.discoverylabs.com. The replay number to hear the conference call is (855) 859-2056 or (404) 537-3406 using the same conference call password listed above.

ABOUT SURFAXIN

SURFAXIN (lucinactant intratracheal suspension) is a synthetic, peptide-containing surfactant. SURFAXIN is indicated for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk for RDS. The safety and efficacy of SURFAXIN for the prevention of RDS in premature infants was demonstrated in a large, multinational phase 3 clinical program that included 1294 patients. Discovery Labs anticipates that SURFAXIN will be commercially available in late 2012.<<

snip

Cheers, Tuck

[Arthur Radley] He admits that the drug works, and since we aren't talking about treating an ing...

Arthur Radley — 3/2/2012 11:11:18 AM

He admits that the drug works, and since we aren't talking about treating an ingrown toenail, rather a life or death situation, I hope that reason prevails in the decision that has to be made. Whether or not I win or lose on my investment isn't the issue.

[fred hayes] Let's hope he's wrong. I'm sure not qualified to judge, and I don't know how cre...

fred hayes — 3/2/2012 10:52:12 AM

Let's hope he's wrong. I'm sure not qualified to judge, and I don't know how credible FDA Tracker is. If he's right on the technical issue, maybe some common sense will prevail here. Having a problem like this come up at this point in the process makes zero sense to me.

[Arthur Radley] Now I'm between a 'rock and a hard' place----if this guy is right! Traders Ey...

Arthur Radley — 3/2/2012 10:28:24 AM

Now I'm between a 'rock and a hard' place----if this guy is right!

Traders Eye Discovery Laboratories (DSCO) Ahead of March 6 PDUFA Date, FDATracker Sees Issues
10:12 am ET 03/02/2012 - Street Insider
Biotech traders have their eye on Discovery LaboratoriesDiscovery Laboratories (Nasdaq: DSCO) ahead of next week's FDA PDUFA date on Tuesday, March 6 for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants.

Volume today is already matching the 3 month average.

The FDA classified the review of the Complete Response as a Class 2 review. If approved, SURFAXIN would represent the first synthetic, peptide-containing surfactant for use in neonatal medicine and provide healthcare practitioners with a potential alternative to the currently approved, animal-derived surfactants that today are the standard of care to manage RDS in premature infants.

FDA Tracker for one doesn't think the drug gets approved, saying Discovery Labs won't be able to demonstrate bioequivalence since it changed the formulation.

FDA Tracker concluded:The high variance inherent in whole-animal biological activity test assays will prevent DSCO from meeting established inhaled albuterol bioequivalence standards when assay agreement is examined in a Bland-Altman plot. This is purely a statistical problem due to the nature of the assay " DSCO s next option moving forward is to conduct a clinical trial using the new formulation and demonstrate consistency in the clinical outcome as the FDA originally requested.

We have no doubt Surfaxin works. We would approve it based on common sense because it appears to be effective and safe from the clinical trials. If DSCO had stuck with their phase III formulation, they probably would have been approved a long time ago. But because DSCO changed the formulation, they have to conduct an unprecedented bioequivalance trial for a surfactant delivered by lung lavage. DSCO entered uncharted regulatory territory, where they became stuck between a rock and a statistical hard place " a nightmare scenario for any company seeking drug approval

[fred hayes] To my knowledge the value of the drug or trial data has never been challenged by...

fred hayes — 3/1/2012 5:11:14 PM

To my knowledge the value of the drug or trial data has never been challenged by the fda. I think you're going to be fine here, but you never know for sure...

[Arthur Radley] Considering they actually used the product in the clinical trials they surely we...

Arthur Radley — 3/1/2012 4:07:46 PM

Considering they actually used the product in the clinical trials they surely weren't using a defective drug---so perfecting the production process surely can be accomplished. I HOPE!!

[fred hayes] Pretty sure it has always been stability and mfg issues. I would bet on approva...

fred hayes — 3/1/2012 12:14:18 PM

Pretty sure it has always been stability and mfg issues. I would bet on approval this time, surprised if it doesn't finally cross the finish line. But I have no concrete analysis here, it just feels like it's now or never, and I think this drug is needed and fda knows it...

[Arthur Radley] Thanks! I picked up a few shares today @3.65-----gives me a reason to watch as ...

Arthur Radley — 3/1/2012 11:52:21 AM

Thanks!
I picked up a few shares today @3.65-----gives me a reason to watch as we approach their due date.

If it's only a manufacturing issue---I would like to hope their new partner for manufacturing has some solutions for this issue as the data appears to show the drug works.

[tuck] Slightly better than even? Beats me. A poster I respect was not sanguine about...

tuck — 2/29/2012 10:43:17 PM

Slightly better than even? Beats me. A poster I respect was not sanguine about the hiring of additional manufacturing talent after the last flame out. Picked it for the contest, and my Mom has a few shares that have reverse split enough times, we probably will still lose money even if it's a blockbuster. But really don't know how to call this, and don't own it myself.

Cheers, Tuck

[Arthur Radley] Tuck, FDA decision time is next week(7th)---what odds are you giving that DSCO f...

Arthur Radley — 2/29/2012 3:37:08 PM

Tuck,
FDA decision time is next week(7th)---what odds are you giving that DSCO finally has it right and the FDA will give them approval? Is the 5th time the charm?