Optimal timing for share price rise and sustain:
There is no debate that a “one hit wonder” including approval for PDD (that’s Parkinson’s Dementia, not Parkinson’s Disease typically thought of as the motor control atrophy a la Michael J Fox) would shoot the price up from $5 to $20 in a day and retrace to $7-8 same day. Look up Sonoma’s recent 300% jump on approval. After 2 days, went back to trading at pre-approval price and has remained.
That’s not even up for debate. The company knows it, the traders know it, the institutional buyers know it, no mystery.
(Oh, as to revenue producing if approved...takes time to get the marketing and distribution in place, so that’s going to leave an opportunity for the price to stay low until sales begin. The drug has to be on the market before it will be reflected in price. PDD market is a fraction of the overall PD market and even off label use is not a large revenue to factor in because insurance won’t cover, and it takes some familiarity with the drug - effects and side effects in the general population by PCP’s before it is used off label - hysteresis.)
Missling knows that our share price will not be maximized for shareholders (such as himself) by doing this piecemeal.
Anavex started the trials at certain times (PDD, Rett adult US arm, Rett adult Aus arm, Rett Aus Ped arm, AD Aus/expansion sites, 3-71 initial safety and exploratory). The company has control over when it applies for approval to conduct trials and approximates enrollment times. (Take offs are optional; landings are mandatory.)
Continuous multiple rolling catalysts are the strategy which can sustain a small biotech’s share price once and for good to a launch pad to sustain higher levels.
Here’s the sensible plan. See if this looks like a window into the market’s soul with more than a remote view of what Anavex has lined up?:
PDD results - take as much time as you need (Anavex) the longer the better - you guys, you GET it!)
Mid to late Aug or into Sept = ideal.
Good results, the price will shoot up and want to retreat. But...
Rett US was announced overenrolled by 50% on 6/16/20. This means that as of 7/10/20 (yesterday) the extra (last) enrollees in that trial (Adult US Rett, 7 wk) were 4 weeks into a 7 week trial. Add 3 weeks - July 31.
Allow time to lock and analyze data for the trial - will include ~30 patients, visible endpoints such as seizures, fewer sites than PDD, and ODD ensures priority FDA review.
So, as the first play (PDD) is whistled dead, we are in hurry up offense and scrimmaging for the next play...Rett results will be hanging over the heads of traders who dropped after PDD.
If PDD results are good/promising, this includes proving out the precision medicine subsets in order to enroll a ph3 which will be a statistical walkover, this is where ‘tutes should take positions. The traders who dropped will have competition for shares and we can raise funding at higher prices with less dilution.
The US Rett has a completion date of Sept 31, and has been powered up by larger n. Perfect. Results will be imminent after PDD if PDD is in August. Imminent meaning could happen within 2 wks to a month. (Sept window)
With good Rett results and safety, approval virtually guaranteed.
‘Tutes should pile in at this point with growing momentum for a tidal wave surge in successful outcomes/revenues/business/profits/ sharp share price increases.
At this point (late Sept-mid Oct), the Aus Adult Rett should be finishing, with a completion date of Dec 31, 20.
If US Rett adult results are good, the next plays are obvious and timed at optimal strategic intervals all the way through to AD/partnership...
Touchdown.
For optimal share price appreciation and sustained growth to capitalize on our carefully placed catalysts,
I can’t envision this going any other way. I can’t envision this going wrong.
And...don’t forget the 3-71 results - cherry on top.
Also, a consortium in there and trials for many more CNS indications on through 2021 and future with a proven MoA and no further issues with funding and likely quicker enrollments.
If PDD results stretch until August, I’m thinking that Dr M is thinking what I’m thinking, we got this!
And, no going back:)
Calls from the playbook for the weekend. Have a good one and study up -
Biostock
