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Message: Back to the FDA

The other point I would note is the conference call.  DM said "data data data". Dr Wong stressed that "once the data has been presented, it will be viewed as essential and most useful in bringing Apabetalone to the market".   

I am interpreting that to mean (along with the "rigorous academic requirements" statement) that a) data at least matched their pre trial expectations (RRR at least 30%?), b) the secondary end points and bio markers have gone the right way.  

So if the drug is safe ("for chronic drug use") and the broad hints are that perhaps only the 95% confidence interval was not met (from whatever data we have so far)...then the implications are clear.

We have a smash hit of a drug on our hands.  But to get ahead, we need the FDA's blessings (which in turn pretty much decides what share price we will get from any buyer).  Given the pressure on the FDA to to bring out "more drugs more quickly", I think the FDA should be favorably inclined to give us a pleasant surprise.  

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