He bought some!
You might like to see it but they would be mad to do it right now....
Very interesting question. And, if the latter, what size envelope?
" several hundred thousand pages?" I find that hard to believe (words, perhaps, not pages?) but, if true, I am gobsmacked.
Exactly. Most folks don't really understand the level of statistical sophistication necessary to analyse modern statistical trials (clue: if you've never heard of RA Fisher, you haven't even begun...). Consequently there are many different, equally valid ways to analyse trial data, and the method you choose depends on what you are looking for and the relative importance of all the various results that might emerge from the trial. Therefore it is not inconceivable that what the FDA are asking for is a re-analysis with a different slant: you might say, they could do this themselves but that's not their job so they are entirely correct in throwing it back to the CRO who will, of course, have all the raw data plus anything they may have collected but not included in submission. I'm not saying this is the case, or even that it is the most likely, but what the CRL asked for could well be something like this.
Good post.
It's your imagination. See a doctor as soon as possible.
The Co never said, definitively, that no new data would be needed. Some on this board did, on their own initiative. And we still don't know whether any of this means new trials rather than a different analysis.
Of course he doesn't. He also makes exactly the same spelling mistakes as at least one other poster - or perhaps they simply skipped the same classes?
Dear Scott, No-one's listening. Go for a nice, long walk.
Not long now...
Can't agree with these conspiracy theories. A larger AB manufacturer trying to influence the FDA would be taking an enormous risk of anti-trust fines in the US, Europe, and rest of world. Just not worth it, even IF the integrity of the whole FDA mechanism could be compromised, which IMO is about as likely as those suggestions that NASA faked the moon landings. If another Co was afraid of the MTFB threat it would be much "cheaper", weighting costs with risks, to simply buy them, especially at these valuations. I can't see anyone refusing, say, 80 pence right now, and that still wouldn't be expensive for a major player. So no, for me the most likely scenario (and we will probably never know ...) is the administrators in the FDA finding every excuse to slow things down while their wages weren't being paid - we even have some circumstantial evidence for that (lovely charts BTW) posted on this board.
They don't need FDA approval before they sign agreements, which could come at any time, although they might be NDAs.
Scooby
Think of it this way: would you say "I have been bitten by a dog" or "I of been bitten by a dog"?
The only people he could possibly fool are the completely uneducated, a bit like Trump...
" The lack of engaement with te FDA on trial data/ design (considering the previous failure over QT prolongation and liver issues).." Do you have a source or reference for that claim?
I guess that also goes for your previous post that didn't make any sense either??
.. start to the day.