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Re: PlentyParanoid post# 250326

Friday, 11/30/2018 8:14:00 PM

Friday, November 30, 2018 8:14:00 PM

Post# of 403047
"Here is the interesting part. One might assume that BTD would results in FDA granting more Priority Reviews for drugs with BTD than for drugs with just FTD (BTD being so 'crucial'). Not so, as one can figure out from the above table. ALL approved drugs with FTD had also priority review, so did ALL approved drugs with BTD."


It would be more interesting if the goal was Priority Review, but obviously it's not. I'm looking forward to the Table...actually just stating the facts would be plenty...that tells us for a given recent period of time:
1. How many drugs that applied for FTD received the grant? How many of those were subsequently approved?
2. How many drugs that applied for BTD received the grant? How many of those were subsequently approved?

That would show that the grant to application ratio is a lot higher for FTD grantees, wouldn't it? (Of course it would, the standard is easier to meet.)

It would also show that the grant to approval ratio is a lot higher for BTD grantees, wouldn't it? (Of course it would, they met a higher standard in order to achieve the grant.)



"Priority Review is not automatic consequence of either FTD or BTD."
It's also not the ultimate goal. Approval is. And I think you'll find...in fact I suspect that you already know...that a BTD grant is far more statistically significant in terms of the likelihood of an approval than a FTD grant is.

"BTD? We don't need no stinkin' BTD!".
No, it's not needed, but the chances of approval are significantly better with it than they are without it. Right?


But maybe you have some numbers to prove me wrong?

But can it core A apple?
Yes Ralph, of course it can core A apple.

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