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Agreed.
Just a side note, I'm honestly as impatient as the next person on the pace of progress, but I am super hopeful that as precision biomarkers are agreed upon with regulatory agencies, future indications will be approved faster.
The accelerated approval for Lecanemab "LEQEMBI" was based upon a Phase 2.
"Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBIâ„¢."
https://investors.biogen.com/news-releases/news-release-details/fda-approves-leqembitm-lecanemab-irmb-under-accelerated-approval
Of note, there was a concurrent P3 already completed and ready to read out the top line at the same time as the accelerated approval based upon solely the P2.
The P3 trial completed before the AA was granted but the FDA had not seen that data
$AVXL was a pure trading position from 2015 to about 2018 and that's when I liked the story enough to change it to an investment position.
So what was the cost basis of the shares you sold at $9.20 and what was the holding period since you're claiming victory yet nobody asked. So I'm asking.
I've been on the $AVXL buy side since 2018 and that's never changed, so that's my boring story.
Top notch entertainment for sure!
I'm a retired position trader. I grasp many investing tactics and strategies and my timeframe for $AVXL has always been years not weeks.
Let's see where $AVXL is over the next few weeks.
Sometimes you see, I have other plans with some of my money, than having them FOMO locked up in $AVXL.
I know difficult for many to grasp concept.
For Alzheimer's disease, blarcamesine will be granted an Accelerated Approval with no need for another P3 precision medicine formated trial, only a follow up P4 for confirmation.
I do believe the precision model will be utilized for patient selection in other planned trial indications.
LOL, penny wise yet pound foolish. Enjoy your $0.46 gain.
Just to maintain my not posthoc trading record, I sold my $8.74 purchases yesterday @ $9.20 at a massive 46 cent gain per share
It's rather obvious that the collusive MMs & HFs have hired full-time FUDsters.
$AVXL is not a "normal circumstances" type position in my opinion.
My advice is to be wary of letting technicals get in the way of making a good trade based upon other criteria.
Over my career playing with speculative equity, "Scared money don't make money"
"pivotal" is definitely a maybe, but I'm an optimist.
Future trial designs will be pivotal phase 2/3 trials from the start.
When a company has a suite of biomarkers to integrate into trial designs, it increases the ability of a company and regulators to agree on earlier pivotal phase 2/3 studies.
Pipeline link:
https://www.anavex.com/therapeutic-candidates
Interesting in the 3-71 section that Anavex is looking at P3 trials for the three diseases and no P2's, if I read it correctly. Is the 2-73 analysis being tied in with what is known about 3-71, that the connections allow for Anavex to go directly to P3's for 3-71?
P.S. Not sure if the color shade has any significance, i.e., navy blue (2-73) vs. sky blue (other 3 drugs).
Nice article, nice science, shitty stock.
$AVXL has a strong balance sheet with no debt and a simple equity structure, $NWBO doesn't.
I know $NWBO is a penny stock promoters favorite here, but comparing an lifelong OTC level company like $NWBO to one that has long since advanced to the NASDAQ Global Select as $AVXL has done is naive.
The real issue is the piss poor capital structure and negative common shareholder equity due to debt and issuance of a new preferred series of convertible shares because the common stock is worthless.
"The NWBO issues is too much cherry picked premature "transparency" and AVXL is more standard definition of lack of transparency."
I'm excited to hear more about the MJFF biomarker breakthrough that can "objectively and reliably detecting the disease at the molecular level — even before the onset of symptoms."
This discovery will no doubt become integral to trial design and patient selection in the future. But, I read it may take up to 2 years to scale up the technology for use.
In the meantime, the MJFF partners in Australia, "Shake it up foundation" are finalizing the trial design on a Phase 3 PD trial using an already "compelling suite" of biomarkers.
https://shakeitup.org.au/new-treatment-shows-clinical-benefit-in-patients-parkinsons-disease-dementia/
The biomarker suite is compelling for approval.
I believe that question was answered. Focus on the dismal historical track record, and "the unknown" for your dark sarcasm. It keeps me entertained while I wait. I hear it just around the corner.
"As far as next steps go, we are expecting full comprehensive results of the entire AD 2b/3 trial, which will be presented via paper or otherwise. After of course, we look forward to speaking with the FDA, EMA, TGA, and other global regulators. We believe our biomarker suite is compelling for approval."
Ok. So with all endpoints of the P2b/3 AD trial met, then what is Missling waiting for then before speaking to FDA et. al?
The biomarker suite is compelling for approval. So I'm ready to see those dribs and drabs.
Looks to me like that huge cash pile at BP's is starting to be put to work, and the valuation collapse in biotech is a perfect time to strike deals. Many BP's have pipeline gaps they need to fill and others want to expand and diversify.
Could get interesting.
Another company in phase 2 acquired.
That huge cash pile at BP's is starting to be put to work and the valuation collapse in biotech is their perfect time to strike deals.
https://www.reuters.com/markets/deals/gsk-buy-canadas-bellus-health-2-bln-2023-04-18/
Have you taken a look at $RXDX Prometheus' investor deck?
I think it backs up your idea a Precision Medicine P3 trial will take place and my assumption is per plan it will be via a partnership for AD. Or a BP simply acquires $AVXL to minimize the hassle.
Being of an optimistic slant, I give a 15% chance for your comment below for AA.
Obviously no discussions with the FDA or others until that deep analysis is done. I give a 5% chance that regulators will accept SIGMAR1 mRNA expression and whatever other correlated biomarkers are found from the deep analysis for AA.
Also of note $RXDX had 89.11% (ex 13D/G) institutional ownership. But...$RXDX also had a handsome sweet talking CEO who had just successfully raised $500 million. So I found it interesting that $RXDX was flush with cash yet agreed to be acquired by $MRK.
Probably, but it was an interesting structural change at this time nonetheless.
The roles of CEO and Chairman of the Board have been separated with Dr. M as CEO and Jiong Ma as Chairperson.
It was basically a needed move to mitigate some of the OTC level stank left over from the companies origin.
Venture capital had to come from somewhere... lol!
Hopefully not one of Christopher’s old school buddies…
This is my venture capital allocation, fundamentals what's that?!?
$AVXL fundamentals are fine in that what is required is simply cash on hand to end of trials and a line of credit. Check and check. I have joked that LPC is like a "Best Buy" card versus a platinum Visa. LOL!
Yep, 2023. It's just around the corner.
Getting some $XBI upside alerts today, that's always nice. Let's see if capital flows are shifting toward risk now that some FED uncertainty has been lifted.
$AVXL should of course benefit and that's a technical and ETF structural thing and WITHOUT company specific "WGT" news.
Don't miss out.
New biomarkers and technology seems to have taken a nice move forward lately too.
I've noticed over my career, when the stock price is down, the "public" has issues grasping positive developments, yet will ascribe value to FUD.
Regarding MFJJ developments, while we've been waiting for our MJFF study to start the technology and science around us has moved forward in a way that will strengthen 2 upcoming Anavex trials.
First is the small PET imaging study and second the trial design of Anavex's PD study slated for Australia.
https://www.michaeljfox.org/grant/evaluation-anavex2-73-blarcamesine-participants-parkinsons-disease
https://shakeitup.org.au/new-treatment-shows-clinical-benefit-in-patients-parkinsons-disease-dementia/
Institutional ownership should be viewed relative to the securities history.
There are often baby biotechs with 85% or more institutional support when their origin story is created by Wall street. Other times institutional ownership starts at zero and moves up as in $AVXL's case of which is the very, very rare case of a security rising up via uplist from the OTC to NASDAQ Global Select top tier.
A deliciously oversold opportunity at support for the brave believers.
I don't think retail truly understands how small Anavex is or how important it is to spend money as judiciously as possible until the "facts" are known.
Markets go in cycles, some ride the waves others get crushed in the rocks.
Companies that raise funds without facts in biotech are common and usually they spend it all and go back to the market a couple times well before "facts" are known. Talk about waste of shareholder value. (BTW, I've made a lot of money playing the hype cycles)
Biotech is usually fake it to raise funds, then they fail on the facts. Anavex was not promoted by Wall Street to "fake it" so I do give Anavex the benefit of the doubt due to its non-traditional history.
Meh, biotech is dealing with the unknown.