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Re: no2koolaid post# 226344

Tuesday, 09/06/2016 10:56:23 PM

Tuesday, September 06, 2016 10:56:23 PM

Post# of 444853
actually, the number may be closer to 16%. If one examines the article in question the exact wording is:

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.

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