Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Annie who wrote (912)	5/7/1998 11:45:00 AM
From: Stephen How	Respond to of 1432

Is Asensio wrong here? In his latest press release (May 7), Asensio writes: "The fact is that regardless of Mr. Crossen and BioTime's false statements and claims, the FDA will not allow the use of Hextend without a limitation on dosage, and physicians will not use Hextend&reg beyond those limitations." I don't believe there is a "dosage limitation" per se in the Dupont Pharma Hespan&reg package insert (http://btim.dyn.ml.org/Biotime/hespan.html). In the insert, in the Warnings section, there is a note on transient effects of hetastarch on the coagulation mechanism (see insert). In the Dosage and Administration section, under Dosage for Acute Use in Plasma Volume Expansion it reads only: Doses of more than 1500 mL per day for the typical 70 kg patient (approximately 20 mL per kg of body weight) are usually not required, although higher doses have been reported in postoperative and trauma patients where severe blood loss has occurred. Asensio may not be literally correct in his statement. I think the FDA allowed this wording in the Hespan&reg insert because of all the prior research showing no effects on coagulation, including a single study that safely applied 5 L hetastarch to 4 trauma patients in a 24h period, and 15 L to a single patient in 24h. In other words, it seems that the medical community has some vague understanding about the dosage limitations of hetastarch. However, as hetastarch induced coagulopathy is not 100% understood (or even agreed upon -- many researchers find no coagulopathy problems with hetastarch) I think doctors have a vague uneasiness with hetastarch. Steve btim.dyn.ml.org

To: Annie who wrote (912)	5/7/1998 12:21:00 PM
From: Keith J	Respond to of 1432

Well, I haven't seen Crossen's report, so I can't comment on the accuracy of what Asensio is referring to, but what exactly is there in Asensio's press release that is real, and not just semantics and ravings? The title: "BioTime Analyst Issues False Report" The argument over whether the bankers and lawyers said things vs. company employees saying things. Misrepresentation of uses and sales potential? Well, it's possible he may half a point here, but this is really ancient history from what I understand. Then Asensio follows that with a true statement from Crossen's report. Then he follows that up with usage limitations, yet doesn't indicate what Crossen has said in his report that wasn't accurate. Do we know if BioTime recommended a maximum usage to the FDA? By the way, is there a usage limit on Albumin? If not, why not? If so, what is it? We don't know what the FDA will say about dosage, and neither does Asensio. Safety claims? Again, what did Crossen say? By the way, if Hextend is allowed in larger doses than Hespan, couldn't you infer it's safer based on that alone, irregardless of other safety issues? Claims about market size? Hextend could surely replace the entire hetastarch market, no? So if Hextend replaces albumin at all it's expanding the market. What if you'd like to use albumin, but it wasn't available and you had to use something else and decided to use Hextend. Again, what did Crossen say? In addition, there's a big distinction between an analyst having a belief that something will happen in the future and an actual historical fact. That doesn't necessarily make anything false or improper. Look at it this way, all health care analysts have to have beliefs on whether a drug will pass FDA approval and what the market sizes are. Are they always right? No. Big deal. Anyone making predictions are doing just that, and aren't creating facts. Well, if Hextend and hespan are the same, why is the FDA making BioTime conduct trials and submit information instead of just letting them market Hextend? Define a drug. A drug is any animal, vegetable, or mineral substance used in the composition of medicines. A medicine is a compound used to treat disease, injury or pain. Doesn't sound like there should be any problem calling Hextend a drug, IMO. Besides, didn't BioTime just file a New DRUG Application? I guess if you're Asensio, you know everything, you can predict the future, and can not leave anything open to interpretation. FWIW IMHO. KJ

To: Annie who wrote (912)	5/7/1998 12:30:00 PM
From: Saul H Rosenthal	Read Replies (1) \| Respond to of 1432

Since David Crossen is apparently, from what I've read, a PhD with years of experience in the field and has been the CEO of his own biotech firm, and Ascensio is just a short seller, one would have to be very cautious about believing Ascensio. He is sounding desperate in this release, which is odd as he has been making money driving the price of this stock down. He also distorts things in subtle ways by not telling the whole truth. For instance he emphasizes that there is no "statistically significant difference" in bleeding between the two. That was because of the small group size which was all the FDA requested for rapid approval. However, EVERY VARIABLE related to bleeding, blood loss, clotting etc was in the same direction, in the favor of Hextend. For example, the 56 Hespan patients suffered 12 adverse events relating to clotting while the 59 Hextend patients suffered 2 such events. It is clear that a larger group size would quickly give statistical significance. If you were the doctor, which would you use? If you used Hespan and the patient bled and had to spend 3 extra days in the hospital at a cost of $4000, how would you justify it? Would you say that you were trying to save $40 on the cost of the solution? How do you think that would go over with the patient and his family, with the HMO that has to pay the extra hospital bill, with the hospital usage committees, etc?

To: Annie who wrote (912)	5/7/1998 12:43:00 PM
From: Jim Roof	Read Replies (1) \| Respond to of 1432

Anyone who thinks Manuel Asensio is doing this out of the goodness of his heart and to save us poor long investors in BTIM is gullible beyond belief. Asensio issued similar statements when ZONA was 40 and drove it down to 15. It's back up to 40 (or so). I think Asensio actually shot himself a little bit in the foot with this last piece of PR garbage. He has done what many consider to be a mistake in this business of lies. He has answered a critic. I will agree that Asensio has had an effect on this stock. I would also be the first person to vote for legislation that prohibits those with a vested interest in a stock (short or long) from making false PR statements to the 'press'. If Asensio had the balls to say "Intel management is using fraudulent means by which their processor chip speeds are yielding false performance values. The PII series of chips have a specific design feature which enables them to falsely report finished clock cycles when benchmarked. This hidden feature in effect causes the PII chips to inaccurately report the true number of instruction carried out in a specified amount of time. These chips are no better than AMD's or Cyrix's chips which sell at half the cost of the overly inflated PII price." Some people would react and sell. The difference is that there are too many PII's in the real world to make such a lie stick. This is why Asensio targets companies whose products are open to easy misunderstandings. As for his argument on the 'blood substitute' designation I have this. The original statement was made in 1995. In 1995 the technology did not exist for a true blood substitute to be manufactured (still doesn't exist really, but there are enough players in this area for that title to have taken on a refined meaning.). BTIM saying that Hextend was a blood substitute was based upon the fact that Hextend would in FACT be subsituted for lost blood. This seems painfully obvious to me. Lose 2 liters of blood? Infuse 2 liters of Hextend - it can substitute for the lost blood. BTIM never made any claim to Hextend being capable of carrying oxygen or removing CO2. These guys are smart enough to realize that a truly false label would spell disaster to them and the company and there really was no way the medical community, including the test sites, could possibly let such a weak charade continue for much more than 5 minutes. I bought BTIM about 1.5 years ago and I never had any question at all about what their product does nor what it purports to do. Asensio should go after Intel and see if at any time they have described their processors as the 'brains' behind the computer. I think that is a decent analogy and a clear rebuttal to Asensio's 'straw man' arguments. I maight also add that Asensio's reference to BTIM as OTC/Bulletin Board shows that he is willing to lie to get his job done. BTIM is now and has been for about the last week trading on the NASDAQ National Market. I would not trust this guy to take out my garbage. Jim