Replies to post #16668 on Intellipharmaceutics International Inc. (IPCI)

[crimsonreign]

Why do you think the FDA would take 2 months to accept the NDA filling?

[Bjdev89]

How does pps of a typical drug company react to the filing of a nda

[AngeloFoca]

http://www.investopedia.com/terms/n/new-drug-application-nda.asp?ad=dirN&qo=investopediaSiteSearch&qsrc=0&o=40186

DEFINITION of 'New Drug Application (NDA)'

The final step formally taken by a drug sponsor, wherein it applies to the Food and Drug Administration (FDA) for the approval required to market a new drug in the U.S. An NDA is a comprehensive document with 15 sections that includes data and analyses on animal and human studies, the drug’s pharmacology, toxicology and dosage, and the process to manufacture it. When an NDA is submitted, the FDA has 60 days to decide whether to file it for review, or reject it because some required information is missing. The goal of the FDA’s Center for Drug Evaluation and Research (CDER) is to review and act on at least 90% of NDAs for standard drugs within 10 months after the applications are received, and six months for priority drugs.

PDUFA date is set at 6 months from the date RECEIVED, not accepted - so if filed by mid August then PDUFA date by mid February... I'm fairly certain it was also granted priority review... as PODRAS was.