scratchy,
Sorry for the delayed response. Here is a little food for thought. Thanks for your contributions!
The Spain PDD site notes first patient enrolled 9/9/18.
Since then, sites have continued to open (we may be up to 12 now?)
On Nov 9, the first patient(s) enrolled will have been involved for approximately 8 weeks. Assuming whoever is enrolled has been dosed, either with 2-73 or with a placebo, assuming 1 new patient enrolled per week/ per site, we could be looking at - currently - 6 weeks times (average) 8 sites, for example, roughly 50 patients. (Plus or minus some percentage.) The entire trial calls for 120 patients. If we have even a third of that number currently being dosed, some of those will have reached the 5/6 week mark at about the time Missling went to Spain prior to CTAD.
The PDD trial is testing for efficacy in both improved cognition and motor skills.
Would not be surprised if the CEO is observing early results (there is a placebo involved as well as gene biomarkers) in order to determine if we have any positive signals, despite the fact that we do not know which arm or markers they are from if such response exists.
I believe that since this is a comparatively short trial - 3 mos, and results of improvement in the condition were seen early on in the preclinical tests as well as the AD trial, he would have good cause to visit the sites and get an idea of “what’s cookin”. If it is anywhere near what the company has privately projected and meets or exceeds their expectations, this would be useful information to glean before announcing the trial set ups in AU for Rett and registering the AD trial.
I think shortly after the CTAD, in early Nov, we should have some idea if this warrants going forward (something you don’t want to jump into if funds are an issue, as well as the possibility of no signal from PDD, yet...no use using the funding and getting hopes raised if there’s no valid hunch), and this gives the company the option to wait until the trial progresses further if no signal is present at this stage. Of course, if the trial concludes and meets no endpoints, we will have saved money on 2 other trials (even if Rett Org is paying for the Rett trial in AU).
More importantly, I think any early indication coming from PDD will allow the company to strategize the steps necessary to use the AD extension as well as to prepare for the Rett extension to be used for approvals - discussions would have to take place with the regulatory bodies for approvals for these indications based on previous approval for PDD as well as any other objectives which need to be met, such as length of time tolerated, improvement over SOC, the devastating outcomes of these diseases untreated, and the unmet need.
I think that is where our Regulatory Pathfinders alliance will come into play. I think the company will also gain further useful information from the PDD trial, once concluded, from which to launch more precise entries into other indications. Everything we embark upon gives us more information - that’s universal - not just applied to Anavex. It’s just that, where BP’s have not shown a pattern of using the information they gained in the past to alter their approach, Missling & Co appear eager to put learned information to greater use.
I would expect the radio silence could be broken after the CTAD in second week of November, but would not be surprised to hear nothing, until we need to raise the share price to tap funds from CF. So far so good, so quiet means we don’t need to show our hand yet...that’s positive. Unlike some, I think it’s best to hold your high trump cards until you need to play them. If we haven’t heard anything that means there’s less trump out and at the end we will be trump tight...which is a nice way to finish your hand.
This is all my opinion, of course.
Personally, I’m hanging onto my position.
Bio
Post script:
I think the Pharma sector is taking a beating because it is in a state of flux. The market does not like uncertainty. Long term investors do not have a compass. This is not a tempest in a teapot for the sector - it is an actual tempest. Hard to know what to do. Many appear reluctant to shelter in place (as would I if I held BP stock - ) new guidances, price crack downs, the lines are being redrawn and its the end of the world as they once knew it - yet, I feel fine*. (REM)
Perhaps the recent rise in the bond yield and int rates will have people rethinking any and all market risk. But, just wait until those trade deals kick in - companies will recognize greater earnings and job growth will result. This is economic territory which we have not seen often or recently. The Fed rate will not affect the market like it does when there are stifling trade agreements in place. This opens up growth to counter rising interest rates. When the market can compete with bonds, CD’s, money markets, and precious metals, you know your economy is unconstrained and is capable of growth in more than 1 area. This observation is relegated to economics - not politics. Politics takes in a far greater amount of territory - this is just one tiny fraction of a nation’s governance.
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