RE: RE: Pennsaid 2% - FDA Approval Risk Thanks Marianne,
I appreciate what you are saying that even if Pen - 2% is approved, this will only provide a more competitive product within an essentially capped market for NSAIDs.
If Pen-2% is not approved, I think most would agree that the generics will be more likely to proceed with their launch since they will not have to compete with Pen-2%. In the no approval senario and generic launch, Nuvo revenues from Pennsaid will decline - further straining the cash reserves of the company.
On one hand we have Coviden who is a major pharmecuetical player with extensive regulatory expertise. They clearly would have thought this through (you would hope) and may have decided to take a calculated risk. On the benefit side, they would save all the time and money to complete the PH III clinical trials and be able to launch Pen-2% a year or 2 earlier. On the downside, the FDA says no and they have to do the PH III clinical trials anyway - and the product launch is delayed by a couple of years from when it otherwise would have been.
Although Coviden can accept this risk, Nuvo not so much. Hence Nuvo's unwillingness to legally consent to a change from the original plan which was to submit an NDA supported by PH III clinical trials.
Given all this, the big question for me is what is the likelihood Pen-2% will be approved? I would think greater than 50% and maybe even as high as 75%, but this is not a slam dunk in my mind. One thing is certain - we will know the answer in March!
John