Quite a squeeze position with 2 companies (POZEN & DENDREON) prior to FDA approval. Pozen has one of the more easier paths towards approval that I have personally witnessed in years. I am pretty strong when it comes to determining FDA approval for products. I am 3 for 3 this year with DDSS, SOMX, and SLXP. I have held all 3 through approval. POZN should be a lock! I have never witnessed so much confidence with analysts & writers in approval for a biotech stock. I have witnessed nothing negative from anyone with regards to the data. More of minor roadblocks that could possibly come up. The SPA has a lot to do with this since the FDA set the clinical endpoints of the Phase III study and Vimovo met them all with statistically clinical significance in efficacy & safety. This is even after the FDA changed the endpoints temporarily only for them to come to agreement with POZN that no changes needed to be made. People ask me of my confidence level with POZN and I say condidently that it is a 9.5/10. I have been holding shares since 3/22 from my first purchase and have planned to hold through approval all along from the DD that I have done and others have provided at the $heff $tation.
If Vimovo does not get approved, I will NEVER AGAIN hold a position in a company through an FDA approval for a drug. Everything I know about the approval process and FDA would be turned on its face if Vimovo is not approved for me. This is a big no-brainer to me and I am more confident with this then I was with the other three. DDSS (7/10), SOMX (7/10), SLXP (8/10), and POZN (9.5/10). What does it for me is the SPA. I just think it is a rare exception when the FDA helps to set the clinical endpoints for a study and a company overwhelmingly achieves them. These are two well known products being used together. From an acceptance standpoint it is something that physicians have been doing since the COX-II debacle. They used this combination from the recommendation of the ACC & ACG which both recommended gastro-protectant for patients taking daily NSAIDs.
These 5 reasons stick in my mind for approval that were addressed in a ZACKS article in March: Reasons why we believe Vimovo will be approved on April 30, 2010: 1. Esomeprazole (approved in a delayed release form as Nexium) is already approved for combination use with naproxen (an approved OTC drug at lower doses). 2. Phase III program met primary endpoint and was conducted under a special protocol assessment (SPA). 3.Significant unmet medical need for patients given the withdrawal of Vioxx and Bextra. 4. ACC & ACG both recommend gastro-protectant for patients taking daily NSAIDs. 5. FDA compared benchmark NSAID safety to naproxen back during the Cox-II issues in 2005. Vioxx was removed from the market and many on the FDA felt as though naproxen + PPI was a safer alternative.
I don't believe there will be a selloff post-approval and that this will be a multi-day run. Out of the 3 approved drugs we followed, the only one that pulled back was DDSS. That was due to the heavy debt-burden and the toxic financing of Yorkville that they entered into prior to approval. SOMX and SLXP were both debt-free and ran hard after approval. SOMX went from $3.90 to over $10 and SLXP went from $31.60 to $37.00. It is currently close to $40/share. POZN has the largest short position of the bunch. They also have partnerships, royalty fees, a broad clinical program, and is awaiting European approval. They have many other forward looking events that will move them higher!
A majority of my starter portfolio is in POZN. Yes it is very risky and I would not advise that others do the same. I (personally) am extremely confident of approval and am willing to take the risk. Everyone needs to trade wisely according to their risk tolerance and financial situation! Either my portfolio moves significantly higher or I could lose half my value and return close to where I started 2010. Sure it is a risk but it also is a well calculated risk. Yes.... I will confidently hold through approval and will not allow the price fluctuations & high short positions to deter me in my condidence and due diligence I have learned and provided. As Friday moves closer we will see if my prediction bears fruit. I would not bet against it! $heff
Short Positions on POZN & DNDN 2 days from their PDUFA Dates.
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