Interesting reactions today. Those who panic easily are clearly spooked. Both pumpers, bashers and neutral traders should all benefit from today's volatility, the only group taking it on the chin are longs but to longs, today is just another rather uneventful day. The call itself was meh. Rett data may or may not arrive before H2 as initially expected. If there's a safety issue that needs to be addressed, I'd prefer for it to occur now than later. Imagine a safety concern popping up while Blarcamesine is pending review, or worse, immediately after approval. From my vantage point, it could be something as simple as the FDA wanting more data to a few kids reporting symptoms that warrant further investigation. If there were anything really bad happening with regards to safety, it would be a material event and we'd find out together what is going on.
Dr. Missling has the full data. He knows which journal will be publishing that data. And he know whether Rett works or not. He's not concerned about the delay. He sounded exasperated this morning because he knew how the market would respond. He sounded like a man whose hands are tied with respect to what he can publicly say, and who is waiting patiently like the rest of us to receive news from the FDA that all is good to go with respect to safety, and that there's a respected peer review to back up Anavex's wild Sigma-1 hypothesis. And perhaps also waiting for more patent applications to have been accepted, otherwise he wouldn't hear the end of it because he rushed to approval before fully protecting his asset.
I have a long position that is insignificant enough to give me much of a reason to stop by here except for entertainment and the occasional morsel of news. Today, we got some big news:
The man literally told us that he is getting the ball rolling in Europe because it's a longer process. To those who cannot read between the lines, the plan is looking more likely to have a simultaneous global launch. Dr. Missling knows exactly when he'll be submitting to the FDA, and by extension, approximately when to expect a response.
But that's a long time away and traders need volatility so they fixate on the arbitrary H2 deadline.
I am not comfortable enough trying to bet on the science of any company. Now the wager is something much simpler: Is Dr. Missling a crook? I feel very comfortable placing that bet because I see a situation where a large number of people are placing an even larger short bet on what amounts to circumstantial evidence.
Look at the big picture, folks. Look where the company was when Dr. Missling took over and look where it is today. Then ask youself two questions: has there been progress and has it been significant? He just told us that the EMA has seen all the data and recommended moving forward with the approval process. He implied that he's trying to time up the FDA approval to be around the same time.
And as for Rett delays, shorts can't have it both ways. They can't claim that Rett is an insignificant asset and source of revenue when there's good news, but then claim that it's an extremely valuable asset when there's ambiguous news. I've said before that Feb/March for the Rett data is when we'll most likely get some more information about Excellence, with FDA submission late spring/early summer and FDA approval around this time next year.
I'll wait. Who wants to wait with me (patiently)?
