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Perhaps a diversified portfolio of biotech stocks consistently all shorted would statistically be the sure route to riches?
Can't answer that, but wonder if it is really an issue?
Here is an SA article from today arguing why AXON is now a bargain:
https://seekingalpha.com/article/4111272-axovant-sciences-buy-bargain-price
But, for sure the Market Cap comparison with AVXL is hard to fathom. Failing in P3 (following in the food steps of previous defeats) versus 'only' having positive safety and efficacy in multiple indications across Pre-clinical to P2 studies.
Second question, 22% according to my maths. But this is the important bit
AE profile similar to that of healthy volunteer Phase 1 data
Partnering for AD, according to Missling, will be at the commercialisation stage. Not until after approval!
The partnering/licensing I was thinking of is in other indications e.g. MS.
If I had to guess, and of course provided there will in fact be a partnership/licensing announcement, then partnership/licensing before CTAD.
Would underpin the share price and put presentation at CTAD in a different perspective making it much harder to use for manipulating the stock.
Fascinating subject Master Protocol clinical trial design.
Here is another very recent paper with many hints that seem to match with Anavex evolving a Precision Medicine focus:
Basket trials in oncology have provided an alternative pathway to new drug approvals in the era of personalized medicine. Cancer may not be the only disease that can benefit from alternative trial design. Diseases having genetic components may also benefit from this trial design. There is certainly a new horizon for this alternative, yet complex trial design. Educating research practitioners on core competencies in clinical research, including an understanding of genomics, in addition to an emphasis on team science and communication, will prepare sites to meet this new challenge.
A couple of points of note from the YouTube presentation, is:
The complexity of the gene characterisation needed for patient stratification. With that also the potential number of patients to be screened and trial arms to fill, in this case for multiple treatment approaches in lung cancer speficially.
I think, this may be a big difference in that A2-73 would be a single compound tested against multiple indications where patients for each indication is being Ariana stratified. The so-called Basket Trial. Another cancer example:
The results of CUSTOM reveal the key strengths of the basket trial design: the ability to identify a favorable response to targeted therapy with a small number of patients and the ability to validate a clinical target. Only 15 patients with NSCLC and an EGFR mutation were enrolled onto the erlotinib treatment arm in this trial, but results demonstrated an overall response rate of 60%. This trial arm was closed early because of overwhelming published evidence of the efficacy of erlotinib, but the data nonetheless illustrate that with an appropriately paired target and therapy, large numbers of patients are not required to identify therapeutic efficacy. Among several emerging models for clinical trial design, a basket trial can be the proof-of-principle validation of a putative target. In future, novel targets may well be identified through an evaluation of exceptional responders before development of a basket trial. Indeed, an NCI-led initiative to identify and characterize exceptional responders for precisely this purpose is currently under way (ClinicalTrials.gov identifier NCT02243592).
Master Protocol Trial
This may not fit exactly with Anavex at present, but quite instructional.
Looks like ever declining SLB rates. Hope it stays that way also after next news for once and for all!
Yeah, pointless old rubbish just as the old corner print shop nonsense.
I have said nothing negative regarding the MS prospects.
Some misinformation threads are just hard to kill. Today we know no more about the MS MTA than a year ago. We will hear what direction it is going soon enough.
Correct, the MTA was never disclosed in any SEC filings (disregarding an interview 8-K filing).
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=135038219
Angelman Syndrome firmly on latest pipeline chart.
And btw. Anavex have released bottom line data as per original trial protocol and stated endpoints, which were met.
In fact Anavex have released more data than they were obliged to beyond the original end date and endpoints.
The question is what is going on the current, and somewhat disturbing, data PR vacuum - time will tell.
I can't disprove your valid concerns and they should be part of proper due diligence.
At this stage we can not know which perspective ends up being the right one, if any.
Take your pick: stay long committed and for sure slightly anxious, or hedge/liquidate one's position and never look back.
I don't think you can equate this interview, which mentions the MTA, as intended formal registration of Anavex entering into an MTA with Biogen.
If as a result of a positive outcome of Biogen's testing a licensing or partnership deal emerge between Anavex and Biogen, then as you say this will be an MDA subject to an 8-K filing.
This eventuality is certainly still possible!
But Anders, there never was an 8-K filing for the Anavex/Biogen MTA.
If there was I have managed to overlook it, in which case I'd appreciate a link to it.
Now let's think - why was Fadiran employed?
We have not seen dose dependency data beyond 5 weeks, no PK/PD data yet, no clarity on interaction between A2-73 and Donepezil, no longitudinal data beyond 57 weeks in the ongoing open label adaptive trial design now with some 2 years of data.
Meanwhile, Ariana has been employed and DNA/RNA profiling has been added to the inputs along with: Baseline scores, score evolution, Population PK, clinical assessment, vital signs, co-medication and more..
Anavex switched to calling themselves a Precision Medicine company somewhere along the trajectory.
I say all of this is precisely to avoid the surprises that can stem from an old fashioned linearly designed P3 study. Anavex is working not to end like Neurotrope and countless other failed P3 trials.
Instead the AD P2/3 trial is being designed to take into account non-obvious uni-directional or multiple variable correlations that can not be identified with traditional statistical stratification methods. Data mining – why KEM?
This way inclusion/exclusion criteria and endpoints can be selected with higher level of outcome certainty and reduced risk of surprises.
That's why it serves no purpose for Anavex to publish piecemeal data, but rather ultimately a coherent trial design and probably pre-agreed approval path e.g. SPA or similar under new rules/guidance that we may be awaiting.
PS! Use google webcache to find the historic URL of interest. You will find in general that www.anavex.com\my_uploads\... retains the archive of files previously published.
Agreed and one of the key reasons I remain invested in Anavex.
In fact, as far as I can tell and I do try to dig deep, Missling has acted consistently with statements he has made for the last couple of years.
No problem!
I do agree that the Ariana KEM analysis may well hold the key to a successful P2/3 trial design with optimum chance of meeting the right endpoints.
http://www.anavex.com/my_uploads/Anavex-June-2017-Presentation.pdf
Slide 36!
Find 5 difference for a prize
Just in case, the slide with that graphic is identical to one in the June Corp. deck and so is not exactly news.
Biogen MTA 8-K filing.
I can't find said filing, only an interview in which the MTA is discussed.
https://www.sec.gov/Archives/edgar/data/1314052/000161577416007701/0001615774-16-007701-index.htm
The MTA isn't even mentioned in any of the 10-K or 10-Q filings subsequent to the 28th September 2016 PR announcing the MTA.
Much appreciated if anyone can provide a link to a SEC filing formally registering the existence of the Biogen/anavex MTA.
Faith is a human ability to believe in something in the absence of evidence.
Anders, I think we agree that it is likely, but not a given, that we will eventually see an 8-K regarding the outcome of the MTA. Hopefully a meaty one.
It ought to mean everything, but I suspect it doesn't the way we'd like.
Probably it means cash to pay regular outgoings and activities, with the extras like trials covered by available funding draw down i.e. LPC and grants.
I wonder if the discussion on Material Transfer Agreement (MTA) and any default obligation to file a SEC form 8-K regarding outcome and completion, might be based in a simple mix up with a Material Definitive Agreement, which is the subject of an 8-K?
This is what we do know about the MTA:
Biogen will test Anavex’s lead drug candidate, ANAVEX 2-73 in an oligodendrocyte precursor cell (OPC) differentiation assay. A satisfactory result from the OPC assay study may lead to an in vivo remyelination study using a chemical demyelination model
Understood. Thanks.
Dado,
In comparison to A2-73, I am curious how you rate GW Pharmaceuticals EPIDIOLEX cannabinoid product candidate for severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS), as well as Zogenix ZX008.
Are we further upstream with A2-73 in addressing the cause of epilepsy than these two seemingly promising new late stage epilepsy candidates?
Thanks in advance for your insights!
Thanks Falconer!
haha. I failed to read your entire message before responding.
Anyway, I am prepared to stick with 1st. April as my genuine bet.
April 1st. 2018.
H1 2018.
Further to this regarding A2-73, my guess is that a "Basket Trial" could be in play.
A basket trial (bottom) involves multiple diseases or histologic features (i.e., in cancer). After participants are screened for the presence of a target, target-positive participants are entered into the trial; as a result, the trial may involve many different diseases or histologic features. A master protocol for a basket trial could contain multiple strata that test various biomarker–drug pairs. Statistical approaches are not depicted in this figure.
coordinated efforts to evaluate more than one or two treatments in more than one patient type or disease within the same overall trial structure.
The common denominator is a need to answer more questions more efficiently and in less time.
T3D Therapeutics another non-plaque-attack competitor?
http://www.t3dtherapeutics.com/wp-content/uploads/2017/01/CTAD-Presentation-09-Dec-2016_website-posting.pdf
Looks good, any science minded views?
Unfortunately, from an investor's perspective, not a listed company (yet).