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Biotech / Medical : IPIC -- Ignore unavailable to you. Want to Upgrade?

To: Harmony who wrote (1224)	5/16/1998 7:45:00 PM
From: P.Prazeres	Respond to of 1359

Here are some thoughts on the 10-Q I think the reason IPIC got slammed this week was because of what was said in the 10-Q... On CerAxon: "A placebo response rate unexpectedly higher than that previously reported in the literature may have accounted for the inability to detect a difference in infarct size reduction and neurological function among drug-treated patients, as compared with patients who received placebo. As a result and considering statutory requirements that would have mandated an FDA action by June 1998, the Company has withdrawn its NDA for CerAxon. " -- did someone accidentally replace the placebo with CerAxon?? Sounds like a stupid question, but why would the placebo response rate suddenly be unexpectedly higher?? 2. On Redux. "The Company does not expect to realize any future revenues related to Redux. " --ouch! maybe they don't want any perception of the studies being conducted to mean that they are implying that redux is coming back. The results of the studies could mean that the lawsuits have no grounds, which should lift the price...at this point the market has discounted redux revenues altogether. Any hint of it coming back will propel the shares. If the studies show that Redux alone is not a problem, the stock will rise because the lawsuits (product and shareholders) will have little merit. Just some thoughts. Paulo

To: Harmony who wrote (1224)	5/18/1998 12:29:00 AM
From: muddphudd	Read Replies (3) \| Respond to of 1359

Pulled the following from yahoo:IPIC by NeuroInv: " 1) I share your optimism regarding pagoclone. The question is not whether GABA agonists reduce anxiety/panic, benzodiazepines are the major class of drugs (SSRIs are now being used for panic as well) for anxiety disorders, but are very nonselective and thus have major side effect and dependency issues. It is the selectivity and resultant safety profile for pagoclone that is so intriguing. 2) On the other hand, I do not share the view that Redux will return. At a time that the FDA badly needed to establish its regulatory credentials in the eyes of Congress, the Redux recall served nicely. The FDA may have acted prudently in halting the sale of fluramines (I do not quarrel with their role in overseeing safety issues) but they went far overboard in their subsequent statements of linkage between fluramines and valvulopathy. Since the FDA only believes prospective data, and all of the studies now ongoing are retrospective (looking back at patients who already took the drug), it is unlikely that they will reverse themselves on this high profile issue without a prospective safety study....a lot of patients taking Redux or placebo while receiving a series of echo studies. Such a study would take a lot of time and money to complete...since long duration use continues to be an open question, we would probably be talking about 18-24 months to enroll and complete all the patients. By the time that was all done, analyzed, submitted and reviewed (early 2001?), there will be more competition and impending patent expiration. The original patent on Redux was to expire in 2000, a 2.5 year extension requested based on the approval time delay. Once-daily Redux was being developed partly to obtain longer patent protection, but that has been shelved. I do not believe that IPIC is going to take the time and money to do this kind of study in exchange for a year or two or marketing exclusivity. To do so might be a boon to the generic manufacturers happy to jump in, but of little value to IPIC. Luckily, there are several other compelling reasons to recommend Interneuron. NeuroInvestment (www.neuroinv.com) "