Carfilzomib chances of approval?

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Anonymous said:
The FDA just fired the first shot at the phase II carf filing. A 22% response rate with significant safety concerns (deaths) in a space that already has 7 approved agents. Looks like we will be waiting for the phase III data. That is about as clear a pre-ODAC signal that I have ever seen from the agency.
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F Off haters!!! 11-0 unanimous vote for approval recommendation!!!
 


















Anonymous said:
RR is about 24% in the study submitted for the FDA review.

OK 15% RR post Vel or Rev

Where is 24% coming from with no control?

Poor study design unfortunately may keep this drug from coming to market soon.
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baaaaaaaaaaaaaaaaaaaaaaaahhhhhhhhhhhhhhhhhhhhhhhhhhhhhhh!!!

Go back to the kiddie pool with your "insights"!
 


















Anonymous said:
FDA will not follow ODACs recommendation. Bet it will get denied still
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Seriously what’s your beef with Onyx? You are clearly taking this very personally, like you’re rooting for Onyx to fail. Why would you care either way?

“Bet it fails’? How many unanimous votes for oncology drugs have you seen the FDA go against? I would say almost none. I’ve been in this game for 20 years and I can’t remember on instance where the FDA went against a unanimous panel vote.

Stop the hating and you will feel better about yourself…
 












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