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Tuesday, February 12, 2019 11:06:36 AM
So how does that functionally work, and what do the timelines mean then? Well, the FDA will likely watch this trial with extremely keen interest due to the safety profile of the drug and the target (TNBC). If the FDA is impressed with the interim numbers for CTC counts, it is very possible that they will ask/allow the company to submit data for review and approval under AA while the trial is still going. The AA process doesn't stop the clinical trial process - it just allows a drug to get to market much faster while the FDA requires the company to complete in progress and, usually, post-marketing studies to demonstrate the clinical benefit and safety profile. The FDA can then revoke approval if the subsequent trials don't prove benefit, or have unacceptable side effects, etc.
If necessary, I can provide examples of where the FDA has intervened during P2's and approved drugs under AA. Google searches will get you the same thing though.
In short, the only date that really means much there in my opinion is the Estimated Study Start Date.
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