Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
AXSM Sun Trust Update(Regarding Implications of SAGE TR Failure):
Today, SAGE (SAGE, HOLD, Lee) reported failure of pivotal Ph3 MDD study (our note HERE) which is pressuring AXSM shares. We see little read-through to AXSM's AXS-05 currently in Ph3 study in MDD given study is run by the company for improved quality control rather than outsourcing it to a CRO like SAGE. We have previously highlighted this in our note (HERE).
As big part of SAGE's failure today seems to be due to study quality control, we think AXSM has already taken appropriate steps to mitigate this crucial quality control risk to mgmnt's credit. Also, we think competitor's set back sets up AXS-05 well for potential commercialization, assuming positive data and approval in MDD.
Also, with recent positive narcolepsy data from AXS-12, we think the floor for AXSM has gotten significantly higher. We are buyers of today's weakness.
Pardon me Dew-Has it really been that long? I guess you could say I've been in a desert of sorts-Of course, at least we can agree that it's possible. Time(and, in this case, not very much)will tell. In any event, have always appreciated your webpage and commentary. Best, BW!
My pleasure Kris-
When a stock has moved as much(percentage wise) as AXSM has, people are suspicious that, for whatever reason, it must be overpriced. So, they start to take a closer look at the nuances of individual trials to ascertain if the foundation & MsOA are sound, which makes perfect sense.
However, in this case, I think it holds up. Although I think the KOL presentation doesn't necessarily mean they're sure they have a winner, it certainly does indicate they're very confident. In addition, I agree with you that the quickened uptake of Melox(& also Riza, though to a lesser extent) via MoSEIC, means that if/when Momentum succeeds, INTERCEPT should be even more likely to, because speed and extended half-life are critical issues in both(but particularly in INTERCEPT). Also, starting INTERCEPT so quickly only demonstrates confidence in this overall MOA.
If they're right, AXS-07 will be a migraine drug that docs & pts will be encouraged to use early and often, because it's proven to be worth the extra cost over existing generics.
As an AXSM investor though, I'm comforted to know this is only one of a number of late stage applications about to read out that could more than justify the current MC(despite this year's runup)all on it's own
Regarding the AXSM Momentum(Migraine)Trial: I suspect that, at the least, compliance issues and other trial unknowns have been minimized since the entire trial is being run thru a single company-managed trial site in Miami, Florida.
In addition, considering that this is a triptan study, I think we can assume that none of it's participants have a Cardiovascular Hx. Therefore, since all have had an inadequate Tx response Hx, I think we can also assume that the overwhelming majority(80%+) have failed on triptans, and are likely(at least to some significant degree)to do so here.
As a result, the superior speed & efficacy of the MoSEIC meloxicam component of AXS-07 becomes a critical curve dividing factor, but when combined with the synergistic pharmokinetics of both AXS-07 components, it's a lot easier to imagine how AXS-07's performance in this pt population will significantly outpace standard Riza., standard Meloxicam & placebo at both intervals(2 & 24 hours).
Therefore, although there is always trial risk, the bar, imo, isn't nearly as high as many appear to expect, and the chances for success across the board are very good
Hi Everybody, I've been in VTGN for almost a year because I like the r/r in TRD, Social Anxiety disorder and MDD. I've been trying to find a copy of the William Blair initiation at $7. Anybody have it available? Would be much appreciated
Certainly a reasonable, though, as you say, thoroughly speculative, explanation of why this outcome diverged so dramatically from the PH2A data(and everything else).
The majority of these patients, as you would expect, could very well have been on namenda for years, and receptor alterations that resulted may have rendered the 30day washout either insufficient, or, even beside the point, if such were not easily and/or completely reversible.
But, again, as you note, we will probably have a long wait to get any inkling one way or the other
By the way, thanks for this response and all of your excellent commentary over the course of the preceding months!
Also, thanks to all the other quality commentators-this is, regardless of the current outcome, an exceptional board!
Ok-On the basis of runcoach's response and link(https://www.worldwide.com/in-the-news/neurotrope-selects-worldwide-clinical-trials-to-commence-services-for-phase-2b-trial-of-bryostatin-for-the-treatment-of-alzheimers-disease/),
I guess I stand corrected.
Nevertheless, I still don't really know anything about this group, their affiliations, motivations, etc., so I have no factual basis on which to speculate beyond what, as I said, still strikes me as a highly unlikely outcome.
Even a trial failure with a marginal, but clearly insignificant, drug effect, would be a lot more believable. Of course, jmo
As a result, I'll be extremely interested to see the followup analysis, thoug I'd guess that's also a while off.
I, for one, have to say that, on the extent of the results divergence, I'm pretty suspicious...Although I don't know anything to speak of about World Wide Clinical Trials.
In view of the entire pre-clinical, compassionate use, and PH2A results profile, a divergence of this magnitude is difficult to explain strictly on the basis of biological probability.
Well, you could cheaply increase your exposure with an Oct19 5/10 call spread...Selling for about $.70 now for $5 payout at $10 stock price, you'd be making $4.30 on your money or over a 600% payout if the trial succeeds.
Could of course also buy at smaller increments, but for $8,000 you'd be making $43,000 on 100 contracts.
One point is, better chance of a fill on larger orders-50 contracts or more.
However, in view of the way things are going, you might even get filled at $.55.if you have an order in at the right moment.
Just some ideas
Simply that you can say just about anything you want, just about anywhere you want, but sometimes the formula for the grammar required can be pretty tricky-I was sympathizing, out of similar experience, with at least part of your statement.
Again, and Again, and Again!!!...
It's definitely a real art form, lol, to point out the obvious at times, isn't it?
If other peoples loss-
Cyosol, I think you may have your answer
Regardless of what AAA says-No risk...That could only happen in Europe!
BTW, does anyone here know-has that been the pattern here at NTRP-To pre-announce the release of data and/or data release events upcoming?
Would definitely be my preference...Get all those shorts keyed up, not to mention the market in general...
Now that may be a bridge too far, in terms of a "Story Book" outcome...But I certainly do share the fantasy!
Any kind of positive results will definitely spook Short investors, as it should!
And so, you're imagined after-the-fact opportunity would/will definitely go up in smoke.
Assuming he'd been focused on other opportunities, I'd guess his thinking(like my own) went something like, "No time like the present!"
Whether we're right or wrong, the purchase price differential really won't make a whole lot of difference.
Short Interest alone will turn it into a "LION" almost immediately...again, Good Luck!
It's September 3rd, and many people aren't even back...
But, like the new holder, who cares what other people think or fail to regarding potentially revolutionary treatment approaches...
Trend followers(the overwhelmingly largest block of investors), by definition, aren't going to get it until somebody tells them to...about a $100 from now...
Best of Luck with that analytic approach!
I'm so with you guys! Alkon puts the entire NTRP enterprise and the prospects of bryostatin for AD and well beyond into such amazing perspective...His depth and breath of knowledge, as well as his appreciation of the AD project in historical perspective is just so lucid and succinct that it has to be heard more broadly!
I know I'm sending it out!
Thanks so much for sharing this!
"That’s all the estimate which, we don’t provide or confirm. It is point in time."
Now who, besides AVXL, would provide estimated completion dates for ClinicalTrials.gov??? You get the feeling, in addition to clearly refusing to answer the question, that AVXL has nothing to do with these dates...that these "point(s) in time", aren't to be taken seriously.
Point taken!
From my POV, and on the basis of just this type of gobbledygook, I don't-
And, therefore, as far as when we can expect these results, it may be 2020, 2021, or never!
WADR...All this "precision medicine" jargon, at least in the context of AVXL-which is to say, in the absence of any statistically significant, control group validated results, strikes me a fairly elaborate ruse designed to buy time in the hopes that they'll be able to come up with something real before the curtain comes down...
Perhaps they will
Oh, and btw, I can see why AVXL would like the "...old double blind placebo shot in the dark" (i.e. the scientific method, lol), to be abandoned-since they haven't exactly demonstrated a mastery of that particular form of "hocus-pocus" to date.
However, that's jmho
I'd say neither company is "one trick" is the sense that they both are seeking a variety of applications...But AVXL seems very definitely predicated on a series of tricks designed to convince the market that, despite the absence of any genuine, placebo controlled data, it should nevertheless be taken seriously.
Not, by the way, saying there will never be any "there there". Just that, to date, there hasn't been.
Or, in the inimitable words of "Flippy"...
Priceless!
an awful lot of "if's" in there...
This is a vapid dialogue that I'm reluctant to participate in further, but, no, I'm not denying that $AVXL is not just a PR stunt and haircuts...
Rather, on the basis of the fundamentals as I know them, I think AVXL may be extremely overvalued, while NTRP is extremely undervalued by the "Market"
So, the "Market" is, imo, and not surprisingly, wrong on both counts.
And, having been in the market for as long as I have, there is no reason to be surprised by this situation, which is why it has zero effect on my estimation of Bryostatin trial prospects...why I find so much speculation on what the "Market" Must be telling us as vapid in nature.
Couldn't agree more...The "Market" is extremely wrong on both counts.
"-market is always right"?
Was it right when AXSM was trading at $2, or any myriad of overpriced stocks trade at exaggeratedly elevated prices right up until their clinical trials failed...Hard to imagine a more laughably absurd statement.
Translation: Not true!
Lol...Too True!
Thanks FBAG-At least encouraging that all the oral studies have been positive...Important thing IMO is that it apparently works in the animal models, and that the oral route of administration is effective.
If there are no technical or metabolism-related problems anticipated, I guess I agree-probably no need to tie up resources. And yes, close to zero chance they'll remain independent.
Thanks!...If you can provide any links, would be much appreciated
Re: Bryostatin in AD...As mentioned, I think one important question is, has NTRP done much work on developing an oral version, and, if so, where are they on that front?
Anyone have any insights?
Well, because AXSM went up approximately 10x after it's MDD Ph2 results(and has a lot further to go, but that's another story), many have suggested that we should expect much the same thing if successful. But that may be too conservative, because, although there are a number of depression drugs(though they're admittedly underwhelming, due to side effects and questionable efficacy), they do work at some reasonable level. And even when they don't, there are alternatives(cognitive therapy, etc.). So AXSM's drug was/will be a significant improvement on what's already available.
But there are no real drugs for AD, and unlike depression, AD is ultimately a life threatening condition in practically all cases. Therefore, the need is much greater and the consequences of no available medications are, by and large, much more severe.
So, I think if the results are really good(comparable to the previous ones), the market cap may possibly go up twice as much...a billion MC over 3-6 months?, for starters. Of course, one big Q mark is, will an oral version be easily and quickly forthcoming?