I'm not extremely knowledgeable in past examples. I know July 26th they applied for the NDA, and the FDA has 60 days to accept the application or request additional info. I don't know as they are required to file an 8k about it, so I'm taking a no news is good news approach. Hopefully this week we'll get a PDUFA date from the FDA and that will give us something more concrete. Oct 15th is another (perhaps bigger) date to look for. We'll recieve the decision from arbitration, I don't know if the decision will be binding, but it will at the least encourage a settlement. I found it interesting that ANAC filed an 8k stating they were confident (which I don't believe was neccessary) and valeant filed nothing (also don't believe to be necessary).
no problem. This stock will fluctuate up and down, but with higher highs and higher lows. You can trade the swings, or just hold, either way you wont' regret it
In many ways kind of a non event, however just the fact that we hear news should stop the slow bleed. ANAC filed for a NDA on 8/26, the FDA has 30 days to accept that and state that the info provided is or is not enough for them to make a decision, then its 90 days till decision time (though often it will come well before that time). With the type of drug ANAC is making, its efficacy and safety, its pretty much a foregone conclusion it will pass, and be a 20% upside minimally from here, I suspect closer to 40% myself.
And don't forget on 10/15 we get a ruling on the $200m+ lawsuit. Anyone selling now is a bit foolish. I think this is a head fake to get out the uninformed
FDA approval for Focalin XR expected for this Month..GL
This Low float Stock awaiting 8 FDA approvals and has another 2 Potential Blockbusters ready for Phase 3
Foclian XR alone which is Partnered with Par Pharma will drive IPCI deep into Profitability quickly after Market Launch .There is NO generic version of Focalin XR available on the Market , IPCI & Par will be the first here and its normal that the first generic takes 30%-40% of market share quickly after launch .
5-6 FDA approvals expcted within 12 months .This Gem has everything to move into Double Digits the Market Cap of $40 Million is a Big Joke .
Market Cap:$ 42 M
Cash : $3 M
Shares Out: 21 Mil..(10 Mil Shares held by Insiders/Institutions)
Low Float: 11 M
8 Generic Drug Applications Filed with the FDA
We currently have eight Abbreviated New Drug Applications awaiting FDA approval. These include generics of Focalin XR® Effexor XR®, Protonix ®' Glucophage ® XR,Seroquel XR®, Lamictaf® XR Keppra XR® and Pristiq® .Together, these products represent approximately $4.78 of branded and generic sales.
Our lead product, a generic version of Focal in XR®, is partnered with Par Pharmaceuticals Inc., a top ten U.S.pharmaceutical company.As a result of a settlement with the innovator company, we expect to marketing of our generic versions ofFocalin XR® upon approval. We have a ten year profit-sharing agreement with Par for the sale of a generic version of Focal in XR® in the U.S.,which commences with the commercial launch of the product by Par .