- There is MNKD the 16 Jan 2010. Didn't pull the trigger on that one yet because they seems to have trouble finding a distribution partner for their drug (Afresa, inhaled insulin). The last inhaled insulin formulation that was put on the market had to be pulled because it caused cancer, so a lot of pharmas are wary of the product, so even if approved it may be a though sell. I will probably buy some if the price falls significantly or if they announce a distribution partner. I am still trying to decide if this is a good bet or if a long term investment in GNBT is better (GNBT should file the NDA for their own insulin product 2H2010, so no approval until 2011, a really long term investment)
- There is IGXT the 6 Feb 2010, I didn't yet pull the trigger either because there is a possible patent problem between their partner and Biovail, and this may delay the approval to 2011 if charges are filled. Again I am waiting for either a price drop or news that the legal stuff has been sorted out.
- I will probably purchase some DDSS too if the price continues to fall. IMHO any purchase under $1.40 is a good deal. The price could reach above $2 in the run up and possibly spike to $3 if approved.
Well DDSS is seeking approval on a depression drug, and with the overall market for depression drugs in the range of $2- $12 billion annually....If DDSS does get approval which is gonna happen--due to the fact that the CRL they recieved did not ask for any additional clinical or efficacy trials...instead the issue was with their manufacturing facilities .....which has been corrected.
Therefore if DDSS captures 10% market share on the conservative side, Please remember that canadian drugs are usually cheaper than american drugs .....we would be looking at at least $5, I think they would sell at least $300 - 500 mill in the first Year due to the fact that this drug cost much less than its competitors ....share price should be at least around $8 - $12.....So guys just my 2 cents
New PDUFA Action Date Assigned by FDA/API Manufacturing Issues Resolved - Labopharm's response to the FDA's complete response letter was accepted as complete and designated as a Class 2 resubmission. The FDA assigned the Company a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010. Subsequently, the Company was informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API), that it had received a letter from the FDA stating that Angelini has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year. The Company continues to prepare for commercialization of its novel antidepressant and, pending FDA approval, intends to launch in the U.S. in the first half of 2010.
NDS Accepted for Review by Health Canada - Labopharm's new drug submission (NDS) was accepted for review by the Therapeutic Products Directorate (TPD) of Health Canada. TPD has assigned a targeted action date of August 4, 2010
New PDUFA Action Date Assigned by FDA/API Manufacturing Issues Resolved - Labopharm's response to the FDA's complete response letter was accepted as complete and designated as a Class 2 resubmission. The FDA assigned the Company a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010. Subsequently, the Company was informed by Angelini, the manufacturer of the active pharmaceutical ingredient (API), that it had received a letter from the FDA stating that Angelini has appropriately addressed all deficiencies cited by the FDA following its inspection of the manufacturing facility in June and July of this year. The Company continues to prepare for commercialization of its novel antidepressant and, pending FDA approval, intends to launch in the U.S. in the first half of 2010.
NDS Accepted for Review by Health Canada - Labopharm's new drug submission (NDS) was accepted for review by the Therapeutic Products Directorate (TPD) of Health Canada. TPD has assigned a targeted action date of August 4, 2010
I like CTIC and CVM.
CTIC has Pix date set at April 2010 but should hear something early in the year IMO. All kinds of rumors about buyout, but rumors are just that.
CVM has facility in Baltimore pending and Multikine P3.
Should be exciting times with CVM. May have already started with the news about John Hopkins and H1N1.
We shall see.
Hoping these and a few more (LLBO, BIEL, VKNG, IVOB, SNDY) take off in these next few months.
Please make sure you have TH in your stock portfolio ...this would double by march 2010 and triple after the FDA review. THTCF is the US symbol. this stock would make you guyz some real cheddar
There seems to be quite a lot of interest in pumping DDSS these days especially from my fellow canucks; however my money is on APPA. APPA faces headwind to get its price above $1 to clear the Nasdaq hurdle in up coming weeks. I will be waiting and watching.
This would likely be my last post for the year. I would take this opportunity to thank the team behind FavStocks for a job well done. Happy holidays and may the trading gods be nice to us in 2010!
[QUOTE=erlik;6278]Here are the ones I watch for Q1 2010:
- There is MNKD the 16 Jan 2010. Didn't pull the trigger on that one yet because they seems to have trouble finding a distribution partner for their drug (Afresa, inhaled insulin). The last inhaled insulin formulation that was put on the market had to be pulled because it caused cancer, so a lot of pharmas are wary of the product, so even if approved it may be a though sell. I will probably buy some if the price falls significantly or if they announce a distribution partner.
MNKD publicly said that they expect partnership to occur only after PDUFA date.
2010 First Quarter Plays
