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Re: daydreaming2 post# 83691

Monday, 12/22/2014 11:55:41 AM

Monday, December 22, 2014 11:55:41 AM

Post# of 402685
Daydreaming - After rereading the PR for the fourth time, I'm in agreement with you. As a matter of fact, my initial take was that this was good news and perhaps FDA is considering granting the QIDP benefits but needed PK to seal the decision. Then after the fallout, I started thinking that I was wrong and that something else was lacking. Leo did seem to take a lot of words to try to say something, (I'm personally not sure what at this point) about ITT and MITT groups.
Then, there's Leo's response to an email from wild4ctix:

We had a very successful few months with the FDA as all our interactions went surprisingly well and fast. I rushed everyone to get the Phase 2b study briefing book to the FDA. I still believe it was the right strategy as the consultants tell me it is rare that you just walk in and the FDA grants permission for a Phase 3. Note that a trial like ours generates many thousands of pages of data. The FDA asking for exact data before the face to face meeting is a good thing for CTIX.

Leo


This doesn't sound like FDA asked in order to grant AA or PR, but, rather that something was lacking. But Leo closes with The FDA asking for exact data is a good thing for CTIX.
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