“Salmon, Rising” II — Of Telaprevir PDUFA Dates, And Unusual Disclosures Of The Same — By Two Companies

Overnight, Salmon offers us more widsom (in the comment box) on the topic of disclosing FDA responses, and the dating of the same, from a deeply-experienced, and nuanced, point of view (Salmon’s own, not to put too fine a point on it!):

. . . .I had also come across the May 23rd PDUFA due date.

My puzzlement was how did the reporter get the AC meeting dates for both drugs. I assume if Vertex was told one date they shouldn’t have been told anything about Merck’s AC meeting and vice versa.

So if the reporter got the AC meeting date from one company did he get the other AC meeting date from the other company, or also from the first company, or did he get it from the FDA, or some third party. In any event it seems to me that the situation is ripe for the potential inappropriate release and possible misuse of information.

Of course the May 23rd date PDUFA date wouldn’t be the date of approval, because no one can know if it will be until an actual approval is given. However assuming no problems (and FDA procedures where the company is now given a heads up 60 days prior to the PDUFA due date) plus the fact that Vertex is gearing up manufacturing. I think the chances are pretty good that we will see an actual approval for Vertex in mid- late May.

March 14, 2011 11:16 PM. . . .

So do stay tuned — we’ll keep you apprised. And again, thanks go out to Salmon!


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