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I feel the same way (caution: I'm a regular joe with no training in bio/pharm.) I've always felt that the delay in release of PK/PD results is to collect as much more longitudinal data to make the dataset as rich as possible to make your case. This is even more pertinent if you observe each progressive dataset to head in the right direction as you adapt the protocol. There is appreciable dispersion among the 25 patients and it needs to be overcome using time and any adaptation of treatment. The statistical crunching is obviously not the time impediment. I do believe 'underdosed' and '+ve response to dose escalation' mean you have completed draft runs on data. You get only one shot at proving to your peers/investors and you want to take your best shot. I think we are close as it appears to me, Missling is showing up at more and more conferences this year compared to last and he always sounds so confident. If he shows stability for 1.5yrs, it is more likely to create shock and awe. The longer the dataset the greater the suggestion of a 'cure' possibly.
I'm the one who pointed out to this board about Knoll and his 100-bagger in Medivation. If he's had more successes, I'm not aware of them. I followed his investments for a while after Medivation. He lost in a big way in Atheronova where he was in big. He may have been in on a few success stories but not early enough to reap large multiples. I get the sense (i could be wrong) he doesn't have training in medicine/pharma (unlike Baker, Perceptive & others who have a staff of PhD's) but he has acquired deep interest, after having been entrusted with big sums. This is often the case with family offices - lots of money and often looking for expertise and trust.
FYI, my post here on Knoll got picked up by the FB group and then got made the roundtrip back here when someone pointed out the FB post here. And I don't smoke anything except the Anavex pipe.
Biostockclub, nice critical analysis and here's another take:
I wouldn't expect a serious partner or investor pulling the trigger without seeing PK/PD data. With 32(25) patients in this study, the PK/PD needs to be that much more conclusive. Missling said something to the effect we have the tip of the iceberg so far and PK/PD is the real McCoy. So yeah, everyone on this board should be craving for it and partners/inlicencers/investors are unlikely to make decisions before seeing it. Knoll is a one-trick-pony who is known to place his bets very early and Park West is a newbie in the biotech space with no other compelling names among their holdings. On a sidenote, Ariana will be producing alternate statistical measures (or so I gathered from info on their website) which I hope have a history of acceptance by the FDA.
FYI the stock market certainly doesn't think much about Neurotrope. Someone pointed out SLB rate at 120% already, a full month before data release. It means prople are desperate to position themselves from the expected downside. Their story/protocol around their candidate wasn't inspiring to me and I'm not doubting the market.
MotleyFoolish article on Axovant for chuckles...
Axovant is trying to do something that most biopharma companies have failed to accomplish: develop a new Alzheimer's disease drug. Alzheimer's disease is notoriously tough to tackle, and the success rate for developing drugs targeting it is absolutely disheartening. Historically, over 99% of Alzheimer's disease drugs entering clinical trials end up in the dustbin.
Business people run around a busy street catching money that's falling from the sky
Odds like that make investing in Alzheimer's disease drug developers like Axovant risky business, but there are two reasons why investors might want to lean optimistic. First, Axovant's C-suite includes Lawrence Friedhoff, who led the development of Aricept, one of the best-selling Alzheimer's disease drugs of all time. Second, Axovant's lead drug in development -- intepirdine -- is being studied for use alongside Aricept, rather than on its own.
In trials, Friedhoff's team successfully proved that Aricept can prevent the breakdown of acetylcholine, a neurotransmitter that's lacking in Alzheimer's disease patients, and now he hopes his team can prove that intepirdine boosts acetycholine production. If successful, then a combination approach of these drugs that increases acetylcholine levels and allows acetylcholine to last longer in the brain could become standard care.
According to ClinicalTrials.gov, the estimated completion date for this combination study is October, so we should have data to examine before the end of this year. To be considered a success, the approach will need to meet primary endpoints measuring the change in baseline at 24 weeks on two Alzheimer disease measurement scales: the ADAS-Cog-11 and the ADCS-ADL.
Undeniably, the history of drug development in Alzheimer's disease suggests that Axovant's chances for success are small. However, the potential payoff could be tremendous. Axovant's market cap is only $1.1 billion, and prior to losing patent protection, Aricept's peak sales were $2.4 billion per year.
March is going to be a milestone month for at least a couple of reasons if not more...
1. 15 month hockeystick data (nike swoosh)
2. MJFF grant award announcement
eureka, yaba-daba-doo, anything will work.
Among AVXL's institutional holders, one that stands out is a proven "early bird"...Knoll Capital of Medivation fame. Will he be able to repeat history??? The following excerpt is from Forbes...
"...the biggest individual winner of the Medivation saga is a little known New York-based investor named Fred Knoll.
Knoll runs a trust for the benefit of his family and it was the fifth-biggest owner of Medivation’s shares at the end of 2015, behind giants Fidelity, Vanguard, BlackRock and Wells Fargo. Those firms, of course, own the stock on behalf of many clients and none of those firms have bet bigger or longer on Medivation than Knoll. His 2.67% stake in Medivation made up 79% of Knoll’s $270 million U.S. stock portfolio at the end of 2015, Securities & Exchange Commission filings show. Knoll’s stake in Medivation alone is now worth $270 million.
Knoll has been betting on Medivation for many years. He has been a major shareholder of Medivation since it was a penny stock in 2005, when Knoll first disclosed owning 15% of the company. To be prudent, Knoll has sold some of his Medivation shares since then, but the stock just kept rising as Medivation developed Xtandi, a $2 billion prostate cancer drug, in partnership with a Japanese company. Medivation’s stock has returned 9,664% since Knoll first disclosed his ownership in the company..."
I think all that the A+ researchers are saying is that they don't see why this particular Sigma-1 receptor agonist would work when other SR1's have not in the past. I picture this as a cursory response immediately produced without looking into the data presented by Anavex. A query from a support group head couldn't deserve any more time. I don't think they have looked into its combined effects on SR1/M1/M2/M3/NMDA, Ca/Cl/Na channels as you pointed out in post# 92445.
OFP, Many thanks for asking the cogent, well researched questions that are much needed on this board. Mylcroft and you are doing us retail investors a favor.
A few questions:
1. What are your thoughts on the strong 6 responders?
2. Do any Alz drug trials see such cohorts sustain outperformance (into 57 weeks) beyond initial phases of testing that may be placebo effect related?
3. Have any Alz drug trials exhibited an upturn in MMSE or ADCS-ADL for the entire study group, not just for a cohort.
4. While MMSE is the most reliable measure acknowledged by peers, is it fair to say it FULLY/COMPREHENSIVELY captures and reflects changes & progression and therefore qualitative reporting of benefits is redundant and shouldn't be considered by the FDA?
5. Are your statements setting expectations, implicitly assuming the entire study group was optimally dosed to full strength? We know Anavex has dropped their claims of synergy with DPZ and that DPZ may be a hindrance, not to mention sup-optimal dosages of 2-73 among patients.
Are you a prospective investor - just curious as to where you are coming from.
I'd love to see the conversation continue and read feedback from others like blu_1, neiu, etc.- even Peter Karol who loves charts.
Noble Prize...yes
Nobel Prize...no
Bagholder Prize...very tough competition against Axovain't
This looks and quacks like a high-school experiment. No MMSE, Cogstate, p300, etc. just an "i told you so"
Tiny group genetically predisposed to Alz. (reminds me of the Chilean tribe or was it Colombian) what is it - 0.5% of all Alz patient population?
Antibiotic trial design for Alz trial? 3 weeks?
what's the safety profile?
Ticker symbol (NTRP) shows up in this so called "Journal of Alzheimers Disease) WOW!!!
$100m+ mktcap???
Plato, if you want shares at $1 each, you are late to the party.
From the facebook community "anavexnow" below...
Anavexnow
December 30, 2016 at 7:47am ·
The Phhase 2/3 for Australia is accepting names of interested parties:
Caulfield Hospital: email : adclinicaltrials@cgmc.org.au
Only know of Australian Trial so far for 2017 for Alzheimers..
Expecting greater details soon..
...so screening has begun in prep for recruitment since the start of this year.
Plato, once p2/3 start date is announced, even without p'ship, stock will be at least $5 (200+K mktcap) or a 25% premium from here. If we get BTD and AA then even more. A solo effort to talk it down with FUD on this msg-board is senseless. Don't hold out for a few pennies...
Wow! This page is the motherlode of a lot of the relevant info I've been missing. AND IT'S NOT MODERATED!!! Thanks!
Summary of Alzheimer's trials landscape...
http://www.businessinsider.com/future-of-neuroscience-drugs-pharma-2017-1
You're exactly right - can't make sense of that chart.
unless "...at least 1 patient" means the lower edge of the vertical bar simply represents ALL patients not treated at all. Then too the lower bound at 57 weeks implies a far >2 decline in 1 year!!!
Have you seen the sizes of each of those deals. You and I can make mistakes over pocket change but one could buy entire nations with the sum total of these deals.
I'm hoping they are all mistakes,nonetheless.
McMag & Others, this is a productive discussion. To continue with your thought, why did Allergan pass us up for Heptares' small molecule agonists targeting muscarinic M1 and M4 receptors?
Why has Biogen passed us up to this date to partner with Rodin Therapeutics in Jan '16 for a HDAC2 inhibitor? Why did BIIB pass us up to this date to partner with AC Immune in April '16 for their anti-tau program?
These are all beyond beta-amyloid busters...
Same goes for Lilly, Janssen, etc, etc.
can you elaborate specifically what alleviated your concerns.
Bourbon, Reddit comments page with full text of Herald Sun article...
https://m.reddit.com/r/Alzheimers/comments/4g4zbg/our_alzheimers_breakthrough_full_text_in_comments/
McMag, very excited in every respect and wish it works. There is no shortage of excitement on this board. That is why I try to sound out my concerns on a large investment (and often they get censored by the moderator for no reason.)
Am very much at ease with the AZ indication. Still feel I have a legit question on Rett.
Rett trial being short with easy enrollment, it will be the first instance of a completed p3 with A2-73 (when p3 follows the soon to start p2.)
Bit nervous that Rett is the 1st indication A2-73 will complete p3 on. Rett/children, I suppose, present a very different histopathology than AZ. AZ is an affliction correlated to aging and broken myelin sheath from impaired oligodendrocytes - A2-73 fixes this. I can see the commonality with MS.
No clue when it comes to Rett. Even if Rett shares the same cause, the impairment may be due to an epigenetic factor to overcome and probably requires treatment further upstream. Are we expecting A2-73 to overcome mutations or hope it symptomatically treats?
Needless to say failure in Rett would take Anavex back to pennystockland.
I'm not sweating over the likelihood of MJFF funding - any thought of receiving grants in 2016 is/was misplaced - my 2c.
Application must have been accepted after the May 18th deadline & qualified for the Spring 2017 award cycle. Can't remember timing.
Parkinson's trial should start in June 2017 if the good Dr. has his protocol ducks in a row with the FDA. MJFF Award will be announced in May with funding available in June.
https://www.michaeljfox.org/research/grant-detail.php?id=28
falconer66a, would you mind sharing the report?
falconer66a, when/where did you first come across AVXL?
Anavex's position: "Similar positive MMSE score effect and no notable difference between ANAVEX 2-73 alone and ANAVEX 2-73 with donepezil" appears to be for PART A, ONLY. (p.19)
I don't think they have said the same for PART B.
If MMSE on p.30 represent the Super 6 Mono subgroup and you compare it to the pooled MMSE series on p.28, then yes there is no noticeable difference in the first 5 weeks but one can argue, a difference *appears to be evident* in PART B data.
BTW 2 of 6 strong responders (p.30) (MCI?-given their MMSE start at 25) appear to respond well off the gates.
Yes, I forgot to mention survivorship bias - upslope resumption is probably partially due to non/poor-responders on combo dropping out. Side note: onus is on mgmt to clarify the unintuitive progression of P300 series (p.24) and they will have to use subgroup data to explain it once they have all their regressions in order.
Interesting article on compassionate use (while we wait...)
https://www.statnews.com/2016/11/08/cancer-drug-compassionate-use/
Gernee, taking a stab at your question, your scenario is a massive leap and I would break it down into smaller steps:
1. BIIB's successful current lab testing signals testing in animal models for MS
2. BIIB's successful result in mice signals p2a safety in humans for MS
3. BIIB's successful MS p2a result signals p2b/3 testing (when you say "upcoming trial" don't mix it with Alz testing please)
All this takes time.
Moot point - when do we get the partnership announcement?
With event 1?
With event 2?
I think the submission deadline for MJFF grants is sometime this month. The announcement for grants awarded will be in March 2017. Our study wasn't close to complete to meet the deadline for awards to be announced this month. This was clarified earlier on this board.
What about them mice??? Are they equally vain and are they duping us too???
Xena, I was citing frrol's quotes in his reply to your post.
To my earlier comment "pooled data shows nothing," it's more in the context of us retail guys on the scent of a gamechanger. I'm sure any decline in pooled Part B data post 31wk, will still beat DPZ decline. This is a safety/dose optimization/long-term tolerability study. So this statistical contortion may be for P2/3 design. I'm ready to take my lumps over the remainder Part B press releases but in my mind we have a new game, once P2/3 trial design is made public. I feel pretty good A 2-73 works (with Hampel et. al. comments in mind.)
Last point to note - in alluding to collaborative efforts, it seems like Missling has moved on from usage of the word "partnership" to "inlicensing"
Ariana's services: "solutions for clinical trials that have issues" and "cannot [otherwise] demonstrate clinical benefit statistically"... good development but I don't read this as an all-round good situation for AVXL to be in...AVXL is implicitly acknowledging that pooled data shows nothing going forward (averaging effect) and AVXL is banking on (single digit N) stratifications only to do the talking. That to me is a lot of lemon squeezing for a lemonade. Glad this doesn't taint BIIB's and MJFF's perspectives.
I don't know why all the talk on the board is for a sale of AVXL. I think the good doctor dropped big clues when he used the words "in-licensing" and "no dilution" in the face of trials to come. Juxtapose that with the huge options grants just doled out - 1mm total contracts doled out on 9/22 on the back of 861,429 contracts to the good doctor on 7/18 - that's effectively a 4.65% dilution. One might say "only if they are exercised". I say they are already in the money. Wondering what milestone was triggered.
Anyway, "in-licensing" is a strong word in the face of big pharma, enough to get them peeved - you can't say that with $9mm in the bank. Missling doesn't seem the type with his head in the clouds either.
Selling $100mm worth of shares & warrants and up to 6,754,609 shares, or 18.9% held by LPC. so that's approx today's drop. maybe we settle at $2.50?
i'm admittedly basing my thoughts on very little DD but i was curious why INO had success securing BP partners AZN/Medimmune, Roche (granted it was dropped) and NCI for it's electroporation based therapies while ONCS has been on it's own so far. i doubt it is because INO develops its EP-tech in-house while ONCS outsources EP-tech while focusing on its gene therapy. is it because INO's indications suited BP better while ONCS's indication is a hard-sell or because ONCS's trials are not late stage enough? i doubt both. apologies if my ruminations stem from bad info/assumptions i have made. thanks for all your posts.
why no partnership for ONCS to date while INO got one?