It would have been nice if Vitaros had flown off the shelves as we all had predicted several years ago, right after the time that Health Canada had approved and Abbott was to be our beloved benefactor. How could we go wrong with a non-systemic product that produced erections?
I listened to the call. I can never make any sense out of what is going on in Europe other than we are getting screwed by Damaj's original strategy to spread out the licensing to many companies to foster competition and prevent a takeover of his baby. Maybe we have the right set and number of partners now, but I don't know.
In Europe at this point, I would predict slow improvement but not enough to move the price needle anytime soon. Why not any better? Because, what evidence do we have after all these years that things will be different over the next say two years? Cutting costs is a great move and that will help. But for me, France sales with a good partner like Majorelle should be popping by now. I don't get it. So I am not counting on Europe to help us much in the near term. If any of you think I am reading the EU sales numbers too negatively, by all means chime in.
On the other hand, I think we would all agree that US approval by the FDA is completely different. Approval would guarantee a lot of cash from Allergan or another partner and a share price spike. I am not thinking of say $5 a share but certainly over a dollar a share and multiples of where we are now...and enough to recover some of the losses we have incurred. So there is nothing, nothing, nothing more important than FDA approval. Everything is riding on that approval. Pascoe absolutely knows that. Denner absolutely knows that. And we know that.
I am irritated that we have another delay in the NDA submission, but as Eman has correctly pointed out, the November 17 meeting is considered a favorable one as it seeks to work with the FDA and not fight it. I think Denner privately made it absolutely perfectly clear to Pascoe that he should leave no rock unturned to produce a favorable result with the FDA. And even then, as Pascoe pointed out in the Q&A, there are no guarantees that the FDA won't screw it up for us. It has been 8 years since the FDA wrote its 2008 letter. People have retired from the agency, there are new eyes looking at this. It is therefore prudent for Pascoe to try in as friendly way as possible, to uncover any issues now rather than after the formal submittal...even if it is costing us another 60 days or so.
Quite frankly, I still can't believe that Pascoe negotiated the US rights deal. It is our best and only hope of getting out of the hole that we are in. It is a much better bet in terms of risk/reward than Fispemifene was, in my opinion.
Those are my rambling thoughts in the Dog Days of August 2016. I am a cat person, anyway.
James |
