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The Chinese are now ahead with chemical base pair editing.
No need April 1st 2018 is the date!
Show us that they have NOT filed an IND!
You seem to badly need "...robust 52-week dose dependency OLS graph in the presentation.".
Is there nothing that can replace that for you?
No, just what is on slide 36, except ignoring to read out 104 Week data and in-licensing.
I am unable to find any publicly accessible register of IND filings. All the FDA reveals is historical reports as to the number and types of IND submissions.
There is no obligation for the company to issue a PR regarding IND filings. Anavex appears to only have done so once in the past:
Anavex files Phase I regulatory submission for ANAVEX 2-73 in Alzheimer’s disease
Thus we cannot exclude the possibility that one or more IND submissions are already in the hands of the FDA, or perhaps some other authority like EMA or with the Australians.
Besides, if I have to wait till H2 2018 for the readout from the Rett trial , so be it!
Seizure reduction will be an endpoint of the Rett trial. Hence, I believe we may not need a specific Epilepsy trial just now.
I can't check at present, but did we back when get PR on the IND for the AD P2 trial?
Exactly!
It is just that I suspect Missling knew then that 104 week updates would be folded into PK/PD as part of announcing the resulting trial design, as we now know, at CTAD 2017.
Notice in the recent Noble presentation at 22:52, that slide 38 lists "Phase 2a - Updates on 104 week extension Alzheimer's study". However, Missling skips that in his talk and refers to PK/PD data as the next catalyst!
http://noble.mediasite.com/mediasite/Play/2451c4d03e624780a689acb83b9ddbe81d
Yes, Missling must indeed be quite confident!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134089922
A thought, just a thought watching that Noble presentation again,
but imagine, if you will, what it must be like being Missling presenting at Noble and in general walking around knowing that your company's drug now means several ex-Alzheimer's sufferers are enjoying their lives again in Australia...
You would struggle to keep a straight face and yet wouldn't be able to help yourself gloating just a little bit, tempered only by thinking aloud -
' I must remember the SEC rules and what my lawyers told me!'
Just one slightly important presentation slot missing from your list
Saturday, November 4, 3:15 - 4:15 Late Breaking Communications
LB18 - Clinical Pharmacokinetics and Pharmacodynamics Characterization of ANAVEX™2-73 for Designing a Phase 2/3 Study in Mild-to-Moderate Alzheimer’s Disease
Mohammad Afshar, MD, PhD1, Frédéric Parmentier, PhD1, Ene I Ette, PhD2, Emmanuel O Fadiran, PhD3, Christopher U Missling, PhD3;
(1)Ariana Pharma, Paris, France, (2)Anoixis Corp., Natick, MA, (3)Anavex Life Sciences Corp., New York, NY
The 2018 Francardo memory you have may have been a typo in one of your own posts?
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134050242
Here is some previous Francardo work on the topic:
This is referenced from the 2016 Francardo poster:
https://www.google.dk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&cad=rja&uact=8&ved=0ahUKEwj1ndSAztbWAhXpYZoKHYFwCToQFggzMAI&url=http%3A%2F%2Fbrain.oxfordjournals.org%2Fcontent%2Fearly%2F2014%2F04%2F22%2Fbrain.awu107.full.pdf%2Bhtml&usg=AOvVaw3YmNfCa8MdvjV_CYz5LqbG
And another detailed paper from 2014:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4281425/
Where and when is Anavex trending in searches.
https://trends.google.com/trends/explore?date=2014-01-01%202017-10-03&q=Anavex
And for fun Axovant:
https://trends.google.com/trends/explore?date=2014-01-01%202017-10-03&q=Axovant
In other words one cannot classify "Characterization" as a negatively loaded word .
My post was of course in jest, although with a hint of objectivity.
Firstly the Biotechnology Index contains several companies with substantial revenue, thus not reliant, as Anavex and others, on the binary outcome of a yet unproven pipeline.
Shorting a portfolio mimicking the IBB would definitely be a bad idea. Also in general my proposed idea would be a bad idea given that a short position can loose you more than your original investment. You'd need to be exceptionally skilled at consistently picking the losers.
My point really was that; of course the often cites 99+% failure of Alzheimer's drug trials are overwhelmingly explained in an increasing recognition that their science foundation is not a correct or comprehensive approach.
Anavex of course remains risky and one would be I'll advised to invest more than one is prepared to loose. The risk/reward ratio in the short term though seems to me attractive enough to perhaps consider an overweight rating in a diversified portfolio.
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).
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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.