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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?


To: dave brown who wrote (2834)7/24/1999 1:11:00 PM
From: majormember  Read Replies (1) | Respond to of 4140
 
Dave,

I think we all need to relax and re-evaluate now.

ALL of us are in absolute agreement the procedure
should have passed, all we're doing is rehashing
our own version of YESTERDAY's Story!

It will NOT help whatsoever to take this approach.

If we add ALL the arguments together, (same-day, both eye),
why 24 mo, not 18, wouldn't they have let us known, etc., etc.
IT WILL NOT DO ANY GOOD.....Get IT!

We need to BEGIN NOW finding out what the "REAL" problem
was. Again, ALL who make the same argument (Russ too, I'm
sure is wondering how this happened), DON'T GET IT!

Auric got it, he first told us so July 16th, when he made
his first post. Now I can tell you if Auric "got it", and
he is one of the Best Shorter's there are, so did Asenio,
A@P, MP and countless other Shorts, who, Btw,
are very saavy investor's.

That, my friend, is exactly the point I'm making in calling
for an OUTSIDE Expert to evaluate "Everything" and make a
call on what went wrong. Don't you realize, the analyst from
Sweden, PA Merchant, all the other negative reports that
came out were saying the EXACT opposite of all we said and
thought. They couldn't believe how the procedure WOULD
get approved......so we can post how we feel here, get
it out of our systems to a degree, become poor(er), say
life isn't fair and the FDA are bastards on the take, etc.

Or we can take a new strategy!

Nuff said,
Skane



To: dave brown who wrote (2834)7/24/1999 1:16:00 PM
From: Terry Barcus  Respond to of 4140
 
Where to go with SNRS from here!

SNRS will trade down for a few days, then the co. will announce exactly what is going on with their deal to get the FDA to give their data a good look, and talk with the FDA about a potential over-ride of the ODP, or at least a fast-track on approval. The ODP wanted more data on regression, but this was not communicated to snrs before their meeting, a bit of an ambush - the ethics of which are in serious question. also in question are how so many big institutional guys suspected they wouldn't get approval - and bet the farm on it. It looks very much like a bit of a set-up, and the FDA was very surprised that it didn't get at least a form of conditional approval (the procedure, unlike the cutting stuff they've approved in the past, is harmless, so even if they could get the clinical data in, it could have been passed on condition the clinical data met specs).

There are a couple things that really bother me about this ODP meeting - I really don't like the 'feel' of it. I think there is something highly strange about the way their application was handled, and one of the panel members actually brought a slide-show with a final slide that said recommend non-approval. That means that info. was constructed a few days before the meeting - and that anyone who knew that slide, or any part of the presentation, or the guy, would be able to bank on non-approval. This is a total farce - typical govt regulatory body - and I sense graft on this, somebody wanted to make someone else seriously pay for floating this co, and they've won on it - at least round 1.

Here's why I'm holding almost all my stock (I had to sell a small amount today to cover my margin account):

1. The doctors who did the investigations are seriously invested in the co.
2. The guys I've listened to think the procedure is amazing.
3. The FDA gave approval to same eye/same day testing for expanded
market groups.
4. The stock is in the russell 3000 index.
5. The mgmt team is pushing for a meeting where they can quickly satisfy the FDA req's and get on with marketing the thing.

But, this becomes a time/$ issue - and the timing has yet to be sorted
out - that is what I have to find out and will base final decision on the results of how the mgmt responds and what sort of schedule they release for people.

Thats where its at so far. Will be interested to see where the stock
goes on Monday, but if they get a decent schedule w/ the FDA, the thing
could get lifted - trying to really get a grip on the actual clinical
data too. The co. is fine on 2/3 issues: 1. safety -great 2. patient
response - great. 3. efficacy (how long the cure holds for before the
eye fades back to normal) - they want 24 month comparisons on that now,
v. 18 month (what the FDA initially demanded). The last issue is where
they got nailed by the ODP guys... who want them to turn in results of
300 patients at 24 months. (they've had the patients in the pipeline for
around that amount of time, so apparently it will take tracking them
down, bringing them in and reviewing their regression over that time,
and ensuring they get a special sample of certain kinds of patients
measured - do sex comparisons/age comparisons/etc).

At any rate - people are mostly reeling from the ODP experience. The
co. and everyone involved (including many of the short sellers) expected
basic, conditional approval. I think some big dogs knew that it wasn't
going to get past a couple of the guys they knew would nail it. For a
panel member to show up with a slide show is too wierd...



To: dave brown who wrote (2834)7/24/1999 10:41:00 PM
From: BARRY ALLEN  Read Replies (1) | Respond to of 4140
 
This whole question of the eye correction only lasting 18 months, why wouldn't that be OK as long as it is disclosed to the patient?

Did you know that Myopic Lasik has regression too? I have referred over 30 patients for LASIK in the past year and about 10 of them had significant regression in the first 3 months. Half of those chose to have the procedure redone and the other half came to like the mild nearsightedness (helped them with reading) and chose not to. The Laser companies call this second procedure "enhancement"! Some laser companies like LZRC give lifetime warranties an will repeat enhancements as necessary. Last week one of my LASIK patients had an enhancement and it wasn't repeat LASIK......it was AK as in RK....radial keratotomy! He regressed and had +1.25 diopters of Astigmatism! They performed AK!!! Can you believe it?? What would the ODP say about that one?? Maybe a product recall?

Regression..... not really a great term to use. Everyone "regresses" somewhat with time. It has to do with age and the internal lens of the eye. Same with astigmatism. If one is a -1.50 myope at age 40, then by the time you get to age 60, you have a good chance in being Plano! If one is plano at age 40, then you might end up at +1.50 diopter hyperope at age 60. If you never had astigmatism before age 40, you probably will have 1.25 diopters axis 90 by the time you are 60! If you have 1.25 diopters axis 180 at age 40, there is a good chance it will disappear by age 60. These are natural tendencies of the human eye!

Every LASIK patient Myopic or Hyperopic will have a change of vision as they age! If the prescription changes by more than a diopter, it can be programmed into the LASIK machine. Anything less, can not! LZRC with their lifetime commitment will perform enhancements as necessary at no charge.

Intacs by Keravision will be removed every 2+ years as the patients vision changes and will be reinserted with the new correction. Have not heard about their pricing policies yet and know of not one Ophthalmologist in my area that is recommending or performing this procedure.

LTK had better results on the regression factor than VISX/BEAM at 18 months. What's the problem? What if SNRS offered a life time "enhancement" guarantee? It's up to the patient to pick and choose which procedure he/she wants performed. It is the responsibility of the FDA to ensure safety. LTK is safe and much safer than LASIK and Intacs!

The following is a opinionated statement made to thestreet.com by one of the panel members who happens to be an Optometrist in a teaching position at Ohio State College of Optometry. He probably has no clue to what is going on in the real world when it comes to practicing. Reminds me of my professors who told us that the only way to practice was in the mom & pop setting of the 50's and 60's. They would pooh pooh any new ideas out there and would rarely change with the times. That is why they feel so comfortable in the Academic world. He is probably a microcosm of this illustrious ODP.

"I don't think it's going to be an optimal thing. The transient nature of the technology is a weakness," said Mark Bullimore, an optometrist at Ohio State who served on the panel, told TSC. At the close of the meeting, he said, "I have difficulty convincing myself that I would recommend this to a patient."

Wake up and smell the coffee! Give the patients what they want! 650+ eyes were treated in the LTK study........and everyone was happy!