Ok, then it stands to reason that will be a bigger problem for current/newer filings than older ones, unless a situation like bi comes up that adds time.
who knows what were at
Well, somebody(s) knows. The most the avg wait could have gone up is included in the 36 to 58 months IPCI has had ANDAs submitted. We know the Focalin XR is delayed but not out of sight, is the avg 60 months now? All that means to me is we hold a pharma with a calendar chock full of events centered around NDAs and new cutting edge techs demanded by regulatory agencies and relevant to any drug(pill) with potential for abuse, from Doog's post:
-The Rexista NDA filed with the FDA by end of this year
-An extremely lucrative commercialization partnership deal signed on Rexista
-FDA issuing IPCI their PDUFA date on Rexista
-FDA issuing approval on Rexista and receiving best-in-class designation***
-Completing property purchase agreements greatly expanding their manufacturing capability and opening the door for lucrative manufacturing deals with other opioid manufacturing companies
-Filing at least 2 to 3 more ANDA's with the FDA
-Definite progression on their 2nd NDA Regabatin
-Ringing of the opening bell on the NAZ
***Amended by umiak: if there are 2 Rexista NDAs the best in class will have to wait for the Rexista with Podras. Another important thing to note is the skipping of Phase 3 trial would still apply to the first Rexista NDA w/ it's excellent patented abuse and alcohol resistant tech Hypermatrix™ The other thing to add to the above is the approval of the Podras patents, due in the next few months, another bullish event.
For me this has become a new pharma/manufacturing company with a side biz in generics. I think we see some generic money flow to help support a higher pps and the NDA/to market process on the new drug pipeline.
If over the next year, due to timing of events the company has to add 1M shares (just guessing) I welcome it considering what is at stake and a very small 23M current OS.
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