Explore small cap ideas before they hit the headlines.
Explore small cap ideas before they hit the headlines.
TA (such as stochastics which I use) is very predictive on a random walk model using calculus to determine minute by minute, the trending direction....HOWEVER, it cannot predict a binary event such as the PR we received....that is the domain of crystal ball prognostication
I read the PR and I am sufficiently impressed with some benefits shown and the only slight miss on only one p value.
The orphan status shows that the FDA will look very carefully at potential benefits where no other real approved drugs are comapareable.
Picked up 3k at $6 to add to my original 15k position at $9.50.
The Rett videos are powerful and nice to see.
SAVA....the WGT crowd just loved the anecdotal videos of Rett patients, but how many of you been following Joe Springer's interviews with AD patient caregiver/associates after 3 years and still above their baseline readings. Some fully functional from being totally incapacitated...those are super responders which AVXL has never yet identified with real numbers
Still waiting for Rett data....four days to go!
Joseph, you are missing one feature on SAVA offering re shorts which were at 40% last week: shorts are responsible for dividends which are zero today, but at $50 in a month costs the shorts $17/share....changes the calculus and profit/loss equation....too bad Remi didn't learn from the meme stock that issued dividend by blockchain
if they PRd an EMA, IMHO they would have done the same with FDA if it had happened...draw your own conclusions
talk about the frying pan calling the kettle black
They can't argue with the results if it is in a major publication.
Back in the days when IMMU was in the process if removing it's incompetent CEO, I coined a phrase:
" Good science is NOT a substitute for good business".
Actions speak louder than words and IMHO the removal of the slide deck almost a year ago w/o any followup allowed the stock price to fall to where it is now.
A clean and unequivacable Rett TLR w/o wiggle room is needed and is overdo.
fake rally or not, I booked 3k at $12.50 on the way to. $300 ...upstream/downstream it works and will get approval first....different MOA
Rett had better not be a blow out.
boi, you finally posted a thread that I am in total agreement
tax loss selling is real, but can be a very good strategie for you if your AVXL holdings are in a taxable trading account....done this several times these past 2 years with SAVA:
IF, if you believe AVXL is near a bottom,
You buy x shares in the market this week, then sell x shares after 31 days, but you sell the high priced inventory for the tax loss for this tax year. The new shares have a low cost basis, but if AVXL goes to the moon, you sell after one year as LT gain.
If lucky, the new shares will be higher than the buy price and you make capital gain as well, but you have until Dec 30 to close the transaction.
check ALZ-801 for those who want to do DD and not keep your head buried in the sand. Here we are talking about a pill, PM flagging APOE 4, phase 2 completed with 2 year data, phase 3 325 ptsTLR expected end of 2024.
No ARIA and reduction in tau, some positive cognition gain, other biomarkers tested.
BTW, Alzheon is not a publicly traded company
Again I state...we need Rett and we need it now, complete and unambiguous.
Since blarcamesine has an entirely novel MOA, it's prudent to assemble every bit of scientific support before filing an NDA
tempus fugit....they are running out the clock on AD...
besides Rett....everything else is years away, presuming the competition doesn't get to those indications first...you are NOT being pragmatic
I will not hang around here for years...that is not investing!
Investor was simply inferring to the fact that if we truly had met all endpoints in phase 2b/3 as was claimed last Dec, and that we have "all the data" as you claim, then it would be obvious that an NDA would have been filed within a year of trial completion...of course that hasn't happened probably because this 2b/3 was never filed with the US FDA as a pivotal registration filing, regardless of the claim by WGT crowd to the contrary (but I am sure we will hear that lie again in response)
Again, Rett is the only game in town here and it's been 4 months since trial ended and should be a home run.
Crescent,
I do not share your perspective on a double hit. I can claim that I already had my "once in a lifetime investment lottery ticket", but I have every expectation of having a second.
AD kills by two companies I am invested in would be out of this universe lucky.
So the truth just surfaced and you have no skin in the game?
Hey Doc, we are in total agreement here and my expectation is for easy approval for Rett, with indications of great data compared to recently approved SOC before YE2023. It is the ONLY reason I am holding onto my original 15k bought at $9.50. They had better not screw this up.
Both trials were FDA approved trials. This is a talking point that has been put to rest many, many times here
Therefore, not relevant to Anavex at this point - or in the context you suggested
IMHO...you have your head screwed on backwards....BTW, both SAVA phase 3s have SPA , whereby one is fully enrolled and will be completed within 2024.... their path is clear, AVXL is NOT, other than speculative "intentions".
Rett is the ONLY success story here, so the data release had better be unequivacable, since they have two identical protocols completed for that same indication.
An SPA is a means to insure that if everything goes according to plan, that a clear path to NDA approval is assured. Trial design, sufficient patient recruitment for statistical relevance, well defined endpoints are all key.
"The overarching goal of the Special Protocol Assessment Draft Guidance for Industry May 2016 (HHS, FDA, CDER, & CBER) is to improve the quality of new drug applications (NDAs) and biologic license applications (BLAs) by providing more certainty in the clinical protocol design process. Among its several purposes, the Special Protocol Assessment (SPA) affords an opportunity for the FDA and product sponsors to reach agreement, prior to study initiation, on the design of clinical trials intended to form the primary basis for an efficacy claim in a product marketing application. For sponsors, the overall value of an SPA is tied to the benefits gained by receiving preliminary input and agreement from the FDA on protocol design. By reducing uncertainty and thereby mitigating risk for the sponsor, an SPA can serve as a beneficial and valuable"
I agree with everything on your thread. The conclusion of all these communications/efforts would typically result in an SPA defining the path to NDA....it hasn't happened yet (here but it has elsewhere) so once again we have hearsay with ZERO evidence that anything has occurred with the FDA other than "we intend".
the problem is that the data is confusing with"titration" meaning that all patients do NOT react well to specific doseages. There had been NO breakout of which doseages produce what clinical effect . The FDA wants clarity, not confusion. SAVA gave everyone the same dose pills to mild and moderate and reported all the data. BTW, 47% of all 216 patients in phase 2 with a cognitive gain of 4.7 points, which here would consider "super responders" if AVXL had bothered reported it, but conveniently hasn't
I believe you have to look at the "money" that's backing SAVA.
see what SAVA presents at conf tomorrow afternoon and how it is received
therefore $1249 is reasonable target should Blarcamesine be approved and traditional valuation metrics used.
presume you are being sarcastic..
the rank speculation on this board about buyouts because of rat poop is simply amazing
I will acknowledge a few positive points: PM is still in the conversation, Rett data will be released before year end, complete 2-73 will be published but no timeframe. Hopefully "super responders" will be documented to be able to compare data with other competitive therapies, two of which are finishing their phase 3 trials next year.
BUT rat data is NOT IGN and the next drug is years away, but promising as far as MOA.
you always have big "IFs"....
the market is the final arbiter not the pumping on this board, and with 1.5mill shares today to a new yearly low does NOT instill confidence.
I am not pleased with my original 15k at $9.50, but how long has it been since we heard " better buy here, because you won't be seeing $8 again".
The Rett data is getting long in the tooth and we expect you with your "imminent" diatribe to eat crow if nothing significant happens before year end.
Rett UNEQUIVEABE data is required...it is that simple..
FUD can't exist with unambiguous TLR
How long has it been since we heard "buy now,since we won't be seeing $8 again".
"Hope you are as excited as we are" is another great catch phase along with the term "imminent' ...which was originally around Dec 5th.
"Takes a while to get data properly
organized", but SAVA presented TLR three days after closing their extended CMS trial
And, whatever happened to "PM...precision medicine" that would would enhance by targeting specific features....gone by the wind.
It must be the Cabals, because we are doing everything right just according to plan.
We need Rett and we need it now!
that's a bet I am willing to take...just added 3k to my portfolio ....you had better hope that Rett comes out soon, because AD isn't going to fly here
we need selling opportunities, NOT more buying opportunities
w/r to SAVA: western blots are NOT digital and the whole ruckus is about papers filed before 2012 , before the first SAVA phase 1 trial by years.
Somewhere it was stated that the retention time for documentation is 6 years in CCNY which is why nothing was presented to the investigator, who were NOT the experts in the field. Note that some of the papers had high res photos, and three major journals absolved
Wang of any wrongdoing.
Isn't it odd that a paper dated May gets unofficially released days before SAVA presents at CTAD ???
This is not normal.
for those in the AD WGT following, do your DD w/o dismissing it as irrelevant, on ALZ-801 which is in phase 3 already and will be finished June 2024. Pill form, impressive phase 2 clinical improvement.
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
Fully Enrolled Pivotal APOLLOE4 Phase 3 Trial Progressing Successfully, Enabling Topline Data Readout and NDA Filing in 2024
MOA is great, but great clinical efficacy trumps MOA. Here, SAVA had it in spades and just read the numbers at the next presentation..
Rett is AVXL's gambit
the next SoC for, both, Rett and AD, next year...
How can anyone call that messing up?