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Friday, 04/21/2017 10:12:00 AM

Friday, April 21, 2017 10:12:00 AM

Post# of 97237
ADMP on sale today. Again. The company just sold a bunch of commons for $3.50. Glad I waited to jump in here; this company has been repeatedly responsible for teaching me some hard and ugly lessons about bio-tech investing in the past, but with a PDUFA by June 4, there's more than enough time for the PPS to climb again IMO.


From the last CRL PR:

Because of the improvements that were made to the PFS in response to the FDA’s original CRL dated March 27, 2015, the FDA indicated that in order to support approval of the product, the Company must expand its human factors study (patient usability) and reliability study (product stress testing), both of which were part of the final PFS NDA. The Company believes that it can finalize the study protocols with the FDA and complete the additional testing within a relatively short period of time at an immaterial cost, and submit the data back to the FDA sometime in the second half of 2016. It should be noted that the Company has successfully completed the “volume delivery” issue that was associated with the initial CRL. The FDA has indicated that the NDA will remain open until these issues are resolved.

This is a PDUFA run-up play pitting what seems like a pretty straight forward response to the FDA CRL against ADMP management which instills little confidence in getting the job done.


https://ih.advfn.com/p.php?pid=nmona&article=74391541

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