Replies to post #169138 on Anavex Life Sciences Corp (AVXL)

[Investor2014]

Wow great find. Seems we might not be too impressed with the FDA.

[Doc328]

Interesting find from the Facebook group. To not lose time, they could possibly do the initial smaller study with/without seizures since PK/PD is the main goal and then have seizures as a primary endpoint in the larger phase 2. The larger phase 2 might be international.

[mrplmer]

So it would be in two places at the same time? Great idea.

[XenaLives]

WOW, just WOW! The U.S. is losing its leadership position in drug approval to Australia. Perhaps "lost" is the proper term, already toast....

[plexrec]

whip....excellent find----do keep'em coming !!!! thanks !!

[Biostockclub]

whippinsaw,

Thank you for the link. It is very tempting to say I expected this and would have posted sooner that I anticipated things to play out this was, but Missling beat me to the punch. Was obvious when they PR’d the initial 15 girls will be part of an extension. Only linear thinking was concerned with the particulars of the second Rett trial. We have discussed the non-linear way to move things along in three dimensions and I saw this as his quickest plan to triple checkmate...posted this several times. The key is (and has always been the extensions).
He is moving very swiftly now, and, exactly in the direction which has been spelled out earlier. No surprise.

Here is the (now completely obvious) game plan. No further surprises (although some here should be surprised at how quickly we will go from no approvals to 3 - or more - approvals. Much revenue, giraffe share price coming, partnership/buyout extremely likely.)

This was not hindsight btw, this is the 4th time posting exact same info.


Drugs can be approved (and often are!) overseas, with NO RCT (random control trials) based solely on extensions of trials for drugs which have previously received approval.

The PDD is the quickest - lots of sites open and patient dosing - which has been registered and has an acceptably large population 120 n, and meets placebo control, double blind, endpoints and dosages establishes. This will run quickly. I said the PDD was our strategy. It will work and be approved. Period.

The Aussie AD site - save your time checking the registry...we will be approved for AD without a huge, costly, time consuming trial, based on extension. Same with Rett.

For the analogy fans:
We have one very quickly growing tree which will drop seeds within the season and in less than the time it takes to plant and nurture 3 trees separately, we will have 3 thriving trees established...
And a forest on the way.

That extension in the PR was a dead giveaway. Don’t fixate that it was announced on an options Friday -forests grow where and when the seeds drop. (Chances are high that they had to PR on Friday because they may have PR’d the Aussie Rett trial on M, or T)

And, lest you think 15 is too small for the extension, DMD boys were approved with 3 boys responding out of 12.

Am fully confident we got this - and will have more approvals than many think in a much shorter time. Don’t focus on trial particulars...the only 1 which is necessary is already acting like it - registered, sites open, patients enrolled... Missling is in Spain, ahead of the CTAD but really spending time there...we have the Regulatory Pathfinders on board....international approvals and shortest routes.

Yeah, the extensions are the new trials of the future. The precision medicine approach of establishing biomarkers, and genome match discovery makes all of this possible.

Novartis and the drug Imatinib started the ball rolling with this approach:

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4932294/#!po=95.1923

(4th time for this link! And it never gets old...it’s the new way of getting around FDA broken process) Also note: the approval for their drug cams from abroad first: Canada 2013. This is the playbook.

Gottlieb has mentioned this drug during speaking engagements as an example of an efficient way to bring drugs to market more quickly and less expensively.

If 50 is the new 40,
Jeep Wrangler is the new Cadillac,
Analogies are the new prose...,
Raptors are the new Jays,
Gossip is the new money...

Trial extension approvals are the new giant, 5 year RCT’s!,
And

AVXL is the new { insert favorite overnight Market Darling here}

Missling is the new Sun Tzu strategist, Medicine Nobel Laureate (CNS!), and Gates/Buffett wealth magnate

Thanks whippinsaw for breaking the news! The strategy has been on the board for quite some time, but, now, the cat’s out!!

GLTA,
Biostock

[attilathehunt]

Whip - Thank you for sharing. It certainly appears the Aussies are much more serious about getting potential treatments tested than the “much improved” FDA.