Anavex Life Sciences Corp (AVXL)

[MycroftHolmes]

Re: Anavex- The Road Forward

Hi Mycroft.

As you probably have noticed a lot of steering around Anavex lately.
I/We miss and appreciate your input in these somewhat troubled times . Not because where the present SP is at but because of, for my part, the credibility of Anavex might be at stake here.

My question for you. Since the shift in trial date expectations as to what was communicated previously by Anavex. Do you think that's the FDA holding up Anavex in a for Missling (Fadiran!!) unforeseen way as stipulated by attilathehunt
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=136859759?

Or did Anavex know all along they would not be eligible for "3 trials starting before dec 31" and were boosting this for SP reasons? And do you think that Anavex has overplayed its hand and credibility for now, in that sense?

Looking forward hearing from you.
Thanks in advance.

No problem, my friend. I tend to remain silent amidst the inevitable self-flagellation that occurs during a downturn but I am always happy to weigh-in when asked. (Though I do travel and miss posts so PM if I don’t answer)

I’d invite my good, long friends to take a deep breath. I assure you that the events of the past 60 days haven’t registered a ‘blip’ on the EKG scan of any veteran investor of biotech.

In pre-revenue bio-techs, timelines slip all of the time. I remarked over dinner to another member of this board in October how odd it was that Missling was not doing the typical “Biotech-Two-Step”. Which is to say, it is fairly typical for the CEO to promise a Q4.. then Q4/Q1…. Then a Q1 deliverable.

The surprising thing is not that the Anavex timeline slipped (which it almost always does in BioTech) but how late Missling waited to play the “we will deliver late” card. I personally chalk this up to the idea that Missling fully expected to have at least one trial underway.. if not more.. by the end of the year. As such, I fully believe that he is indeed waiting on imminent IND FDA feedback to begin the Rett Trial.

By the by, I participated in a conversation recently and walked away with the distinct impression that the people at RettSyndrome.org are quite intrigued by SR1 as a target and are looking forward not only to the A2-73 trial but perhaps trying a few other compounds in the pipeline.

As far as mgmt is concerned, declaring a 3 trial start by the end of the year always seemed like a very high bar. It is only because the FDA rules are in such flux that I even considered it a serious possibility. The fact that mgmt set that high bar… and then did not meet it… is something to be weighed when evaluating future claims. However, like gymnastics, I would consider the difficulty of the maneuver as a factor when grading performance.

Only time will tell how Dr. Fadiran performs in his current role but having met the man, I am convinced that he is not taking some wild eyed approach to his regulatory responsibilities. Whatsmore, he seems to really have his finger on the pulse of exactly the type of data analytics that will pass muster with the FDA and avoid additional time in the clinic.

Nothing has changed about the scientific offering of Anavex. In fact, I am a bigger a fan of the scientific offering than ever before and have gratefully added more stock in the 3’s. If the market gods should be so benevolent… I will do another very large buy in the 2’s and drop my break-even to a level I never thought possible.

I follow the science and the science says to hold the line. And so hold the line I shall… and hold it…with vigor.

Cheers

Mycroft

P.S. My opinion only. Everyone must perform their own due diligence when investing in risky pre-revenue biotechs