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Re: Samsa post# 24675

Thursday, 03/02/2017 9:29:10 PM

Thursday, March 02, 2017 9:29:10 PM

Post# of 38634

Numbers....thanks for the DD and finding this. actually, it is exactly this reason why the company does not report ongoing communications with the FDA in PR's. what would be the point if the FDA requests additional information? it may not be that anything was wrong, just additional testing now being required. the whole reason they have dialogue with companies is to tell the company what needs added or corrected for approval. the bashers on this company would take any opportunity to say "see they dont know what they are doing" we already are getting it with people saying they will never get past advisory committee with the FDA with Rexista.

also, then you have the issue like Focalin where because of time, new BE requirements were required and the company was then required to meet new BE even though they already had tentative approval. these ANDA's being filed in 2010, who is to say new requirements were not added?

the only thing we can really say is 100% the FDA has been on contact with the company in regards to their ANDA's on probably more than 1 of them and the company does indeed have a good reasonable expectation as to what is coming. which is why its important to actually listen and read when they put on these conferences to what is said and how they say it. when they indicate "we feel confident the FDA is making progress on the applications" that is telling because they already know what the FDA has been telling them.

BRAVO Samsa! your best post yet... applause... applause... applause ! ! !

Get ready for some nay sayers to start chiming in as to how IPCI never sold a single pill... never got anything approved... and never will!!!

I boldened one point in your post to stress it... A few years back... the previous CFO, after a presentation, at a Q&A session referred to one ANDA application (I forget which - I think Focalin) and expressed that they felt good about it because they had not had any correspondence with the FDA in 9 months... (although it was filed years before) so I assume they are all subject to back and forth correspondence for clarification or what ever.

I thought ANY SERIOUS INVESTOR would know that!!!