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Re: Samsa post# 20522

Friday, 11/25/2016 12:47:23 PM

Friday, November 25, 2016 12:47:23 PM

Post# of 38634
To consider, let’s look at what happened with PTIE. They submitted their NDA on March 29th 2016. They received their acceptance to review from the FDA on April 12th, with a PDUFA date of September 25th. That’s within 6 months of filing, though acceptance to review very prompt after filing.

IPCI will most likely follow a similar time frame, with acceptance for review likely coming much sooner than 74 days and IPCI’s PDUFA date set for May 2017, within 6 months of the filing date.

We must all be pleased they filed within their latest guidance, it sets yet another clock for this soon-to-boom star. I’ll be in touch, looking forward!