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Clinicaltrials.gov IS NOT a final and controlling depository for trial details. Much of the information is archaic as details are often fluid. Changes made and the resulting differences in the primary endpoints reflects the changing opinions of the FDA and other worldly regulatory governmental entities. No regulatory significance is implied to data contained on clinicaltrials.gov...especially when the studies are performed in another country.
Endpoints are not a settled issue until the database is frozen and released. Anavex does not receive the data until after it received a very detailed qa/qc review and frozen.
"Estimated Enrollment...The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study."
They can enroll more than the stated amount if they want.
Non-FB link to Australian Rett article/video:
https://www.9news.com.au/national/rett-syndrome-alzheimers-drug-medical-testing-underway-on-girls-sydney/c28040fa-31e9-45fd-89d3-d180b3a4ff24
PDD gets the lead due to filling the study first relative to the length of the studies. The clock for blinded studies do not start until enrollment is complete and the last patient is first dosed.
Rett preliminary results were for a first subset, open label, to reassure the FDA on safety and dosage...consider a quick P1 for Rett. Once this step was complete the blinded portion of the study enrollment and dosage could start.
Dosages are "Dose restricted to maintain complete blinding" and purposefully not specifically identified. See the company presentations and footnotes '#' at the bottom of the slides for the PDD (22) and AD 2/3 (20) studies. Likely the 10 and 20 mg, when erroneously called out, were place holders and not real concentrations.
Based off of P2a results they are probably 30 and 50 mg for the PDD and AD 2/3 trials. Missling has stated that the PDD dosages are comparable to the AD trials.
Sites like clinicaltrials.gov are not binding and do not include the full details of the studies. More sites are known to be involved...at least for the Rett trials, and updates do not occur on the fly. The PDD trial is still listed as 'recruiting'.
Don't read to much into these sites as they hold little in the way other than general advertising of the trials to gain participants. The trial details are much more detailed and information on clinicaltrials.gov and the foreign counterparts are not binding.
This is a quick trial. It would be better to maintain strict double blind protocol and finish the trial than waste volunteers on an open label to satisfy or curiosity.
Don't read anything into this. Missling has been using this address since at least 2003.
https://www.sec.gov/Archives/edgar/data/1196573/000119657303000001/0001196573-03-000001-index.htm
Normal market fluctuation for a small biotech when there is no news. Don't sweat it. Ride the waves.
Rettsyndrom.org likely has emailed all caregivers in their data base. Enrollment should be quick based on prior comments by this organization speaking from past experience from clinical studies.
I'm sure Biogen doesn't want a bidding war to develop. But we do. Add Pfizer, Teva, J&J, and a number of other heavy weights into the process and the price could go through the roof.
Anavex's platform could potentially mean the end of any CNS focused company as we now know them.
Missling has been around the industry and knows the game. With his compensation structure he shares our interests on the long term and is not looking for a quick out. Another 6 to 12 months should be very interesting.
Biogen may not have made an offer that couldn't be refused. The NMSS could have stepped in with funds for a quick P2. Missling would likely want to hold off further negotiations until clinical data is on the table.
The clinical MS partner could easily be the National Multiple Sclerosis Society. Biogen likely came in with a lowball offer and Missling knows what cards we're holding. Screw Biogen, we'll keep all the chips for this one too.
IP ownership would have been addressed by a standard MTA. In this case, Anavex would retain ownership...which could be transferred/licensed to another party (e.g. Biogen) under an additional development/marketing agreement.
FDA is sloooow. Need their concurrence for trials that will blow the doors off when positive endpoints are reached.
Missling is likely negotiation with the FDA on a SPA to gain fast approval with a single trial. A few extra months here could save years in the approval process.
Vamvakides already signed away rights to 2-73 in exchange for royalties. Moot point.
Missling has never stated that a commercial partner would be necessary prior to commercialization of A2-73. He has stated that they have the resources and plan to proceed with P2/3 on their own.
This said, Missling is savvy enough to take a deal at any time provided the offer reflects the potential value of A2-73. He is also prepared to go solo and to continue to develop A2-73 through FDA approval to gain the best deal possible for the shareholder.
Remember, Missling is one of the largest shareholders himself. The vast majority of his compensation is tied to AVXL shares.
Insomnia has many diverse causes. Implying that the results from the P2a AD study has universal applications is careless. All that has been shown is that insomnia with AD underpinnings was effectively treated with A2-73 in eight patients with no control group.
Could it have a much broader application in the general population? Potentially. Trials would be needed to determine the bounds of application.
Trying to extrapolate the current very defined trial to applications and theoretical markets in the general population only serves as a distraction at the current time.
Anavex has many irons in the fire and needs to pursue carefully selected routes to commercialization. If the dementia angle stumbles a quick P3 focused on insomnia in AD patients would be in order. Additional studies in other forms of insomnia could then be undertaken.
Don't expect insomnia relief endpoint this go around.
Missling has already stated the P2/3 to be 6/12 months. This is way longer than would be needed for insomnia.
Also, they have spent a very long time analyzing the PK/PD. If insomnia was the target the only question needed would be "do you have trouble sleeping" and "do you have AD".
This doesn't preclude them from running a concurrent insomnia study for around 12-weeks using low cost methods to determine efficacy.
The upcoming study will obviously target dementia. They are looking for a $1000+/month/patient market. This is way more than could be justified by another 'sleeping pill'.
Insomnia may be the low hanging fruit. But dementia will be the real blockbuster.
If EVOO had an effect it would be easy to see in demographic data. AD should then be almost non-existent (or at least disproportionately lower)in Greek and Italian cultures.
Patent info is 'public' already. No reason to be concerned if it is 'material' or not. Anyone complaining that it must be PRed is full of it and just spreading FUD.
Even if it wasn't public information it wouldn't rise to the level of 'material'. Something has to be very major to rise to that level. Look at how little information comes out of a BP company.
See the USPTO.GOV web site and enter in Application No. 13/940,352 They have a 'Notice of Allowance' which is basically a letter that says they need to pay a small fee and they will get their patent. Basically a done deal.
Yes Missling has referenced insomnia for possible trial. But that was some time ago (last year) and the current timelines for the P2/3 is stated as 6/12 months indicating more of the traditional indications are likely. Insomnia would be only 12-weeks.
Assuming your interpretation of Nevada law is true (I have no reason to doubt it or concern to further research it) the proxy items could still be geared to forming a 'deal' with a BP and still prevents a hostile takeover 2+ years down the road.
The 10M preferred shares (or portion there of) can be issued without voting rights. Likely a non-voting delegate designated by the BP would be added to Anavex's board of directors.
All this is speculation but Missling is looking at the full game...not just the first quarter.
Bryostatin-1 has not been synthetically synthesized yet as far as I know. Most that read Neurotrope's Jan. 30 PR would assume a process has been found to synthesize this molecule. However, a careful read of the PR shows that this is not the case. It would have been a major breakthrough if it had been synthesized and would have been clearly stated. Only a licensing agreement was signed with a group attempting to synthesize bryostatin (if successful). A viable means of commercial production remains a fatal flaw for bryostatin.
Otherwise, excellent write up.
An outright sale of 2-73 is remote, but possible if you consider retention of substantial royalties.
With the preferred shares being created there appears to be other plans more in the line of a partnership.
Sale of 2-73 possible. Silence likely NDA (non-disclosure agreement). However, many other permutations are possible with a 'deal'.
If there isn't a PR in the morning discussing a release of 2-73 data I wouldn't expect any new info until some time after the shareholder's meeting. It will take some time to finalize an agreement (assuming there is one in the works) before the details are released.
I assume the agreement involves AD and possibly/likely other indications since an NDA for just MS would be more specific and not effect the release of P2a data.
Total speculation on my part but I don't expect to see any new information released on 2-73 this week. This will drive down the share price and will provide a buying opportunity. There will be speculation that new information will be released at the annual shareholder's meeting...again, nothing new released, still tight lipped. Share price hit again. Then in the days/weeks/up to a couple of months following the meeting some sort of deal will be announced.
Partner likely Biogen but could be others. Missling didn't mention them verbally during Vienna presentation when he recognized all other contributors to preclinical funding of the various indications. They appeared on the slide but no verbal acknowledgment. Lips are tight when deals are being made.
Then again, I could be proven wrong in a few hours with a morning PR.
There will be five - that we know of. 2-73 data isn't one of them listed so far:
3/30/17 15:09-15:12 (14:45-16:45) (09:45-11:45 Eastern) Missling. Forum participant “AD/PD™ 2017 FORUM ON TRANSLATIONAL RESEARCH IN DRUG DISCOVERY FOR AD: A PLETHORA OF TARGETS: WHICH IS THE BEST, IS THERE "A BEST ONE"”
RESTORING CELLULAR HOMEOSTASIS: DEVELOPING TARGETED THERAPIES FOR THE TREATMENT OF NEURODEVELOPMENTAL AND NEURODEGENERATIVE DISEASES UNDER THE PRECISION MEDICINE PARADIGM
3/30/17 18:45-19:00 (13:45-14:00 Eastern) Fisher. AF710B (Anavex3-71)
HETEROMERIZATION OF M1 MUSCARINC/SIGMA1 RECEPTORS AS A UNIQUE THERAPEUTIC TARGET IN AD AND RELATED CNS DISEASES
3/30/17 19:00-19:15 (14:00-14:15 Eastern) Hall, Fisher. AF710B (Anavex3-71)
TARGETING M1 MUSCARINIC AND SIGMA-1 RECEPTORS IN ALZHEIMER'S DISEASE: REVERSAL OF PATHOLOGICAL HALLMARKS AND ASSOCIATED COGNITIVE DYSFUNCTION IN MCGILL-R-THY1-APP RATS
4/1/17 8:15-8:30 (3:15-3:30 Eastern) Maurice. Anavex1-41 and Anavex3-71
THE DUAL REGULATION OF OXIDATIVE STRESS BY SIGMA1 RECEPTORS IN PHYSIOLOGICAL OR PATHOLOGICAL CONDITIONS
4/1/17 9:45-10:00 (4:45-5:00 Eastern) Frenkel, Fisher. AF710B (Anavex3-71)
THE LINK BETWEEN PRESENILIN TO MICROGLIA ACTIVITY IN ALZHEIMER'S DISEASE
We may see a PR yet this week...we may not. Time will tell.
Missling may be dealing with bigger issues that are eluded to by the proxy items that warrant tight lips for the moment.
Pulling a scheduled presentation prior to a conference is often seen as an indication of a possible sale/merger/partnership in the winds. I'm not saying this is the case here but if no 15 month or PK/PD data is released this week there could be a big upside to the silence.
Insomniac reality check. Go to the CTAD presentation slides 23 and 24. Only 8 of the study participants baseline showed issues with insomnia. All 8 had no remaining insomnia at both 12 and 26 weeks. Not n=25/Not n=32.
http://www.anavex.com/my_uploads/CTAD-Anavex-December-2016.pdf
If Missling were to primarily target insomnia in the upcoming study the P2/3 would not be 6/12 months in duration. It would only be a 12 week study (and relatively cheap).
That said, nothing precludes an additional study or secondary or co-primary end points in the P2/3 from occurring. Missling seemed to focus on insomnia early on around CTAD. However, that focus seems to have shifted back to dementia since the P2/3 study will be 6/12 months.
I do agree that insomnia could be a quick 'in' for Anavex. However, there has been no mention recently or indications that a relatively quick trial is planned.
Log into your brokerage account, look for a message leading you to a page you can vote. They usually make the process very easy.