Intellipharmaceutics International Inc. (IPCI)

[InTheTrenches]

This website gives simple clarity on each review cycle:

http://www.biotechduediligence.com/blog/fda-pdufa-v-review-timelines-for-ndas-and-blas


NME (new molecular entity) would be 505(b)(1) (e.g. Veltassa/Relypsa)

non-NME would be 505(b)(2) (e.g. Elite's drug or Rexista)


So, this explains why Veltassa/Relypsa, my first example, had a 60 days to accept NDA + 10 month review (NME, standard review).

This also explains why Elite, my second example, had a review 6 months after NDA was submitted (non-NME, priority review).


If Rexista has priority review (I can't see any reason why it wouldn't), it should have the same review cycle as Elite Pharma. Like you, I'm expecting Rexista PDUFA date will be some time in February, assuming NDA is filed some time in August and NDA is accepted by the FDA in October.