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lightrock

06/30/17 4:21 AM

#11517 RE: rwa3848 #11516

That is an interesting thought, but at one point a few months ago the FDA used the word "futile", and so it appeared that the game afoot there is about "the meaning of statistics" and perhaps "necessary to toss Inventiv data and make up for it".

So to accept your thought, I have to suggest that we have to play those other cards as well.

The FDA must have caved-in since all treatment had been applied already up to the point, as in "ok fine, let's just see"; no harm in that which has not already been done.

"futile" is not a good word to be uttered by FDA.

Hopefully I am completely wrong about what this all means, but they said what they said there; and, consider that there is no reason to terminate a "study" (given that all doses already applied) while there may be a reason to terminate further enrollment.

So would FDA say "futile" if it was merely a matter of CVM exceeding its quota of enrollment without approval ?

Meanwhile we have to take CVM at its word "expecting good news"...

It is not beyond reason to consider that a rate of failure in a time-frame like 10 months might match, but diverge significantly at 36 months.

"If you were going to live longer anyway, you will live even longer than that".