More from Neuroinv. (Yahoo thread):
1) No. Even if I was not on crutches and half-zonked on pain meds as I am at present (following minor surgery) I would not be attending. Dog-and-pony shows where companies have 15-30 minutes to show their slides are very overrated, though on rare occasion useful for an unknown company seeking to get on someone's, anyone's 'radar.'But if you look back at a much higher-profile conclave, the H&Q meetings in January, I did a quick screen of how presenting companies performed afterwards; more than half declined. In IPIC's case, not presenting in Bethesda, or presenting, is irrelevant. IPIC is not an unknown quantity, and they need genuine news to undo the murky perception of the company on the Street. July and August will be key months.
2) IPIC will be presenting the Nutt pagoclone study in Glasgow in August, thus it is not news, just a new audience. Now, the timing could be interesting if the pagoclone 2/3 is unblinded and analyzed by that time, it would make for a much more exciting presentation, but that is not the plan at this time. No one knows how the 2/3 study is going other than the patient accrual going well...the results will not be known until the unblinding (late July, early August).
3) Bextra....I am just waiting like everyone else. I had heard a rumor that the Safety Board would meet early in the summer, but the fact is that the ongoing safety/efficacy trends are reviewed with some frequency (the former more closely than the latter...one would not want a dangerous trend to continue until some formal meeting...but in theory any dramatic trend should be flagged)... Re: Merck's drug, I do not recall offhand if they have announced a timetable (Big Pharma often does not).
4) Regarding European return of Redux. Servier reportedly will wrap up their own valvulopathy study this summer...they are privately held, and will say what they want when they want. If positive, since Redux is a big chunk of Servier's revenue, they will undoubtedly seek to re-market. This might provide added reassurance vis-a-vis US liability concerns, but is totally irrelevant to any reintroduction of Redux here. After all, if the FDA was impressed by European approvals, CerAxon would be on the market. I had previously written my impressions re: Redux's non-return, I am pasting it here for lack of anything new to say:
'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. '
NeuroInvestment (www.neuroinv.com)
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