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Tuesday, September 06, 2016 10:56:23 PM
actually, the number may be closer to 16%. If one examines the article in question the exact wording is:
It does not say that 83 were never approved, it states that 83 were examined, thus it may be the actual number is 118 but that the reasons for another 35 were not able to be examined.
As it relates to content within the CRL, here is an interesting point: When we analyzed 83 NDA/BLA filings that never made it to approval (i.e. were finally suspended by the sponsor), only one was attributed to a manufacturing issue.
It does not say that 83 were never approved, it states that 83 were examined, thus it may be the actual number is 118 but that the reasons for another 35 were not able to be examined.
THEY HATE ME CAUSE THEY AINT ME
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