Replies to post #226344 on Elite Pharmaceuticals Inc (ELTP)

[Couch]

Yes indeed; I've been just a bit more than confused that when Nasrat originally submitted the SequestOx NDA he had about a 55% chance of approval via a well posted article that the 11.1% non approval rating is based on......and then low and behold Nasrat responds to the FDA's CRL and then I'm supposed to believe SequestOx's approval rating is supposed to move down from 55 to a 44% chance approval as opposed to the 75% chance of approval in the article.....the one where actual FDA resubmission data is analyzed.

[dr_lowenstein]

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.