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Biotech / Medical : ARIAD Pharmaceuticals -- Ignore unavailable to you. Want to Upgrade?


To: tktom who wrote (4110)2/2/2016 12:12:07 AM
From: Biomaven  Read Replies (3) | Respond to of 4474
 
>>
Would phase 1 & 2 trials suffice the requirements for approval for an unmet medical need granting that both efficacy and safety (at least some if not maximum) are covered under these two stages of trials? Has there been a precedent for this scenario?

Nope.
You certainly can get approval based on a Phase II - here's an example from last year:

pfizer.com

Really good results in a Phase I for the new drug could move the needle. But EGFR is trickier than ALK, and so results tend to be less clear cut.

Peter