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Biotech / Medical : XOMA. Bull or Bear? -- Ignore unavailable to you. Want to Upgrade?

To: Robert S. who wrote (8446)	1/23/1999 3:09:00 AM
From: aknahow	Read Replies (2) \| Respond to of 17367

Thought Cacaito just got through pointing out he thought the Trauma trial was not as well designed as the perfusion trial. While one cannot rule out marginal therapeutic efficacy, if this was the case it would be more probable that the trial would have ended in 1998 due to reaching the specified level of deaths or simply because the DSMB would have said, Neuprex is not working, end the trial. Fail to see why you are so worried that the trial might be successful, since, as you have posted several times, there is no market anyway.<g>

To: Robert S. who wrote (8446)	1/24/1999 9:34:00 PM
From: Cacaito	Read Replies (4) \| Respond to of 17367

1. Trial extension due to marginal efficacy?, It could be, not my first option, but if you go and check the PARS thread example that I refer to, then no more explanation is needed. This example goes with the marginal efficacy theory. Please check: pharmoscorp.com The company publicly gave the total deaths, they did not know at the time the final results, these were not so rosy (still good results for a phase II). The thread has many theories on the pre-results total deaths, few if any predicted the outcome. Message 4077901 Inasmuch, the lower total mortality correlated with a 26% decrease in mortality favoring the drug. They did not have the statistical significance because it was a phase II and the N was NOT planned for it. This study needed about 5 to 10 times more patients, Dexanabinol is going for phase III. 2. Orphan drug status is good for the company. They get tax and compensation benefits, 7 years market exclusivity and practically assured recovery of development costs (100 to 200 millions?) and assured profitability. Plus, if they get market beyond the 200,000 patients (they will not get it in the meningo market, but in the other indications)they still will have the benefits. For Xoma is double goody. 3. Fast track designation, save money and accelerates marketing. They got the phaseI accepted as phaseI/II and straight to phase III in meningo (already a benefit), approval for FastTrack is 6 months, otherwise is unlimited, look at NorthAmerican Vaccine more than 2 years nightmare (The CEO got a coup d'etat, the company is at the brink of losing independence to Biochem Pharma, CEO is suing back, and they are some $50 millions shorter for this. All pharmas want fast track and they are the ones who actually formed a money pool to provide the FDA with more resources to that effect. 4. Trial extension is a conservative play, born out of statistical necessity and Xoma's interest in strong data. Self explanatory. Would I wish a different reality? Yes, but the not so rosy facts are the facts. 5. ABTI, I presented the phase II Betaglucan abstract, the full article got in my hand the day of the news (going to the library is work), I provided the data, the stock was in the process of tanking and some were still believers. The subset data of the phase III was not good and I said so. Before the phase three I urged caution and there were some claiming 90% certainty (which I opposed)and the believers were a rough group. I had a conversation with one member (open in the thread about probable strategies with short and long positions). Overall, not a believer and once the data(II and III were out) a clear prognosis. Please, read the ABTI thread again. 6. Message 6246744 Here you post: "The review article was published in 1998 and I have to believe that a researcher in this field would be cognizant of BPI." This is precisely what I objected to: There is NOT a mentioned of Bpi in the abstract, You has not presented the full article. This is not the way one will believe someone knows, just by pure guessing. Please, provided the full article and showed the FACT proving your guess correct. 7. I did not belittled, neither demeaned nobodies work. You are demeaning Holzheimer review when you are "guessing" his work and post it festively as a fact to "prove" your misipoint. The Lutsar rabbits/meningitis/bpi study is a poor design and the poor result is the proof. Now, there is a positive to it, it showed one way bpi should not be used, this is a fact. 8. REVIEW: I post abstract that clearly mentions bpi as potential (Fact, not guess). I refer to it as a "Japanese Review" (factual and clear). And did not show anything beyond what was stated, and not even an opinion on it. Tharos find it helpful for trying to track the work of the authors and We will see if We can get any further insight. Just plain correct. My Rosy glasses are ON. Back to Xoma.