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gfp927z

08/31/05 12:41 PM

#212 RE: gfp927z #211

Aiming, OT - One of the reasons for the low valuation of PTIE appears to be a general lack of info/guidance from the company. Part of this is probably due to having 3 different programs going at once, but also there aren't enough Conf calls, and not enough time in the Q+A portions of Conf calls to get the detailed trial info/details out to investors (or maybe we're just spoiled by Dr. Stoll, who stresses the technical aspects in great detail, perhaps to a fault). And at investor conference of course, the Q+As aren't usually webcast to the general public at all. It could also be that Barbier prefers not to discuss the details, since it would reveal the lack of normal-sized Phase 2s (IBS), the somewhat unorthodox design of Phase 3s (Oxytrex), the lack of proper drug formulation (Remoxy), etc. In any event, while the very low stock valuation translates potentially into a huge upside for the stock (an easy double/triple), as an investor it's very difficult to figure the odds without having adequate information.

On the surface, Remoxy would seem to be very low risk, but as far as I can tell, Barbier hasn't really explained to investors what the regulatory pathway to approval is (the nature of the 2nd Phase 3 for example). He apparently suggests that they are in discussions with the FDA about getting an SPA established for Remoxy, but there is skepticism about this. The other big question mark creating uncertainty around Remoxy is the lack of info on its formulation, which apparently is still being changed even though it's in Phase 3 (what the heck is that all about?). No one (at least on the Yahoo board, for what that's worth), seems to know much about the subject, and Barbier apparently hasn't explained what's going on.

The bearish view of this lack of communication from the company is that they might want it that way, to cover their tracks and downplay shortcomings in trial size, design, drug formulation, etc.

I don't know. It's tempting to own some PTIE stock for when the Remoxy Phase 3 results come out sometime in September, but I'm not sure these results will be all that surprising (against placebo). I may decide to just wait til later in the year, until after the (hopefully) disappointing IBS results, and then re-evaluate the situation. Then you might be able to get in in the $4s. I have at least a reasonable amount of confidence in Oxytrex, and Remoxy looks like a very likely winner (need to get answers to the re-formulation question though). Ah, the joys of biotech investing ...
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DewDiligence

08/31/05 3:58 PM

#213 RE: gfp927z #211

Absolutely correct, gfp. Open-label studies in IBS are meaningless. Regards, Dew

p.s. Please see my Zelnorm comments on the BV board.