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Sunday, January 11, 2015

A P 26113 Approval In February...or more likely July?

Looks like approval might come earlier than we thought. 


Here is a recent  article which estimated time from BTD to approval at four months.  


However, I did the math, using data published on the FDA web site (FDA) as well as press released from individual Pharma companies re BTD announcements.  I found that the average days to market was 235, or roughly 8.8 months.   That would suggest an AP26113 approval date somewhere around July (my estimate in a prior post was August, so not much as changed).   However, as I noted previously, the approval can be as fast as 55 days (Amgen's Blincyto), or as long as 498 days (Merck's Keytruda)  

Hang in there everyone. 

TC


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