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The TGA made it clear that anyone can apply...it is plain English and interpretation. Anything other than that is noise and The stock will eventually react to the potential until then engaging with the wrong interpretation is pure waste of time and board space.
-vg_future
bassparks79, actually it is kind of a clarification for the any doubters.....
From the link....
Normally, therapies have to undergo thorough evaluations for efficacy, quality, and safety before they are made available. However, physicians may request to use medications that aren't approved but showing benefit to patients. "We are honored to support medical professionals and their patients seeking treatment for Alzheimer’s disease," Christopher Missling, PhD, the president and CEO of Anavex, said in a press release.......
-vg_future
The HL Pharma NEWS link might be down for some updates or maybe the site is busy due to too much traffic (excitement about the NEWS). It looks like authentic and genuine NEWS but.
However, various interpretations....
- one thinks the RETT part is not authorized...yet (This is possible.... it will reappear after some updates)
- one thinks that the medicine is not available beyond 21, so no distribution needed
- one thinks it is a fake NEWS
You know where you fit....
For the patients who are waiting for a cure.....it is a very real and exciting NEWS....
I will wish and pray for them.
-vg_future
OPinions stated as facts....nobody knows if the TGA is processing the PA request from Anavex (or if Ananvex put in the request), so why opine that it is not given because of the efficacy proof of the medicine or otherwise. Regarding SAS, anybody can apply and it is upto TGA to approve. Without the details, I cannot say that it will not bring in revenue...I strongly opine that it will bring in revenue. Time will tell.
JMHO,
vg_future
SAS cat B is applicable to all who can apply and get approved for...not just for the trial participants. The statement in the NEWS article that TTT has posted is not limiting the availability...it is available to all including the trail participants.
-vg_future
TTTav66, the RETT comment in this NEWS is interesting....any thoughts....potential NEWS on the horizon?
I wish this NEWS got enough airtime last week itself. It would have kept some of the concerns off of this board and also would have helped the stock price.
TIA,
vg_future
Excellent find TTTav66! Interesting mention about RETT in there. So, we are getting another NEWS piece soon........yay! Excited!
vg_future
Thanks Paheron. Very timely and very useful medium to reach wider and much needed audience.
-vg_future
Great analysis and summary. Thanks Bio.
Yes, agreed. This is a real show of confidence on Anavex's drugs and the Anavex's approach and ability to make it happen.
-vg_future
Great NEWS! An excellent proof of confidence in Anavex and the ongoing trials. A PA will be received when it is, until then Anavex cannot give away any hints to partners or foundations like these. A commitment for funding doesn't mean that it has to be used...when the PA comes through or Anavex gets money from SAS (or otherwise), Anavex may or may not need to use the funding from the foundation. So, it is all positive from all angles.
Waiting for the next piece of the puzzle....
vg_future
frol, I suggest you read the PR and the follow up communication with TGA and IR and see how they align. I read it multiple times and I understand what they meant including how carefully it has been worded to stay within the guidelines and regulations. I have zero doubt...and don't need confirmation/validation.......yet again.
-vg_future
powerwalker, thanks for the Jefferson's upgrade. I am trying to locate this research report. Do you have more info on this...target price and other?
TIA,
vg_future
Anavex and most importantly the TGA has clearly stated that Anavex's SAS approval can be used by other AZ patients. Period..end of discussion and end of fancy/imaginary/narrow interpretations trying to limit it to the trial participants.....not sure how many times this has to be stressed upon. Any further attempts are very self serving.
Goodluck to the real longs!
-vg_future
I am assuming that you are being sarcastic in this response. The event will be material only when the patients/doctors starting requesting...so, 8K is not required now. That doesn't mean that the SAS authorization will not contribute materially to the company's finances and/or strategy. So, the 8K requirement theory doesn't hold water.
-vg_future
Yes, you are right. Even a conservative math would also result in a significant revenue stream for Anavex. Where are the analysts with their analysis of this great NEWS....at least some partners would definitely be looking at such potential.
vg_future
JWC3, couldn't agree more. It is the closest to PA with the additional steps of doctor's requesting permission and insurance covering the costs. Unfortunately, the much needed attention or bang from such a great NEWS is not realized.......yet.
-vg_future
WOW! Thanks for the information/clarification from TGA. Finally from the horse's mouth for folks who are not willing to take Anavex's IR's answer. This is great NEWS! Hope some analyst sees this and puts a proper note out. There is a reason why Anavex scheduled a CC at 11 AM (market hours)...they were hoping that through proper questions, the answers could be provided which make the analysts (more importantly the street and investors) realize the significance and potential of the NEWS.
-vg_future
Thanks powerwalker. That's great NEWS. Clint cannot be anymore specific than he was with you. It just boils down to people not willing to let go their thinking (driven by whatever reason) and listen to what the company is telling them.
-vg_future
Lima4918, unless this is a sarcastic comment, this is totally false statement. We did get useful info from the call. CLint clarified the SAS and opined (maybe not, but I will leave it at that for now) on PDD readout.
Lima4918, I hope you are not discounting the SAS clarification/confirmation that Clint has provided. His feeling about the PDD results could be just his opinion. But, again, he could be echoing the general sentiment in the company which is good enough while we wait in the dark and have no clue about the results. Again, this is IMHO.
vg_future
Investor2014, I disagree. The company raised a small amount and maybe only until some point (date) when Missling got the hint (or maybe unofficial word) of SAS approval. The whole "21 patient/participant thing" from the PR is just a start and is ignoring the potential of the numerous requests that would follow.
-vg_future
Just a thought. The 11 AM call was a big step and was setup (IMO) to be able to provide any clarifications and show potential of SAS, but, unfortunately the right questions didn't come up on the call in spite of the NEWS being released the day before (enough lead time which I think is also done to create/generate the interest).
Considering this, can Missling write an investor letter to clarify SAS (assuming that it can be properly and legally worded) under the context of many queries to the IR? I remember some letters like that in the past from CEOs of other companies' which keep getting biased and manipulative NEWS coverage. Straight word from the horse's mouth. No confusion and mis-interpretation.
JMHO,
vg_future
Thanks for the tidbits sokol. EOM.
Biostockclub, very good point. Best approach by the company. Give the participants the much needed continuation while giving a chance for the non-participants to get the medicine. Great!
Got your PM...I don't have PM privileges, so posting here. Thanks for the PM.
Reposting the original msg with modifications.
Taking what IR has afforded as clarification/confirmation is a genuine attempt by long term share holders (or patients and patient families) to see the value of the stock reflects the potential and also get the word out so that patients get access to the much needed treatment.
vg_future
Quick thought....call writers could be worried as well with so much potential in the stock.
Yep. Some analyst should be able to see this potential. If not, potential partners definitely will.....sooner than later.
Based on the response from IR (someone posted this on the board), it is available to all who apply for the medicine. So, considering the restrictions on Anavex regarding advertising/marketing, I will take that as an official stand from the company.
-vg_future
I understand that the initial allowance is for 21 participants.....but, We have to also understand that is because the requests were made only for those patients for the initial approval. Now that the approval is given, other physicians can follow the lead and request for the medicine/treatment. Anavex’s PR doesn’t say that it cannot give it to others.
Let’s see how the things unfold in the coming days/weeks.
-vg_future
Folks who keep saying that SAS is limited to 21 participants only should call the IR and confirm for themselves before saying anything otherwise. Or else, it is just spreading mis-information for whatever reason.
On the other hand, we got folks who called IR and got confirmation that it is available to all who apply and get approval.
vg_future
This SAS might be the reason why Anavex stopped raising further money at these cheap prices. Missling might have had some hints (if not the actual approval itself in his hands). Based on the NEWS, either the stock has to go up significantly for them to sell or SAS might bring in the revenue needed for continued operations at Anavex . Next quarterly report (revealing the outstanding share count and cash at hand) should be very telling...of course we could have many significant events before then which will eliminate the need to look through the quarterly reports for the tidbits.
Goodluck all!
-vg_future
Gernee20, great find. Looks like a very good option for Anavex to supply the medicine to the needy patients.
-vg_future
Steady_T, good point. That is what I am trying to say in my other post...I am not sure how many people read it...Anavex cannot comment in a way that could sound like an advertisement/promotion and it cannot say that it is ONLY available to the existing participants.
People might want to believe and spread what they want to. I have an issue if it is not marked as an opinion. When you have an opinion, be bold to accept and announce that it is an opinion.
-vg_future
Believe what you may want to...I think the approval is for any AZ patient under the care of a physician who can make a request with proper paper work. The company cannot advertise SAS, so it only talks about the patients under the trial now for 5 yrs. As the IR has confirmed, anyone can apply and get approval (as long as they can justify). I highlighted few things from the PR the other day which are worded in a way not limiting the reach. My inserts/thoughts in RED.
Compassionate Use Special Access Scheme Approval for Alzheimer’s Patients to Continue Treatment with ANAVEX®2-73 (blarcamesine) after Completing the 5-Year ANAVEX®2-73-003 Phase 2a Clinical Study
They cannot advertise, so they can comment only on patients in trial
NEW YORK, Aug. 05, 2020 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) diseases, today announced that patients from the ANAVEX®2-73-003 phase 2a Alzheimer’s disease trial will continue treatment with ANAVEX®2-73 (blarcamesine) via the Australian Government Department of Health - Therapeutic Goods Administration (TGA) compassionate use Special Access Scheme following completion of over 5-years daily dosing of ANAVEX®2-73 (blarcamesine) and recommendation by their physicians.
The TGA approved the Special Access Scheme Category B applications based on the safety profile of ANAVEX®2-73 (blarcamesine), as well as clinical evidence that ANAVEX®2-73 (blarcamesine) may benefit patients. Anavex will facilitate continued access to ANAVEX®2-73 (blarcamesine) through the Special Access Scheme at the physicians’ request.
Again, cannot advertise or market. This doesn't preclude Anavex from facilitating it to other AZ patients if there is enough interest and TGA approves requests from the physicians
“We are honored to support medical professionals and their patients seeking treatment for Alzheimer’s disease and who have very few medical options,” commented Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “The Phase 2a clinical ANAVEX®2-73-002/-003 studies are exploring the long-term effect of daily treatment with ANAVEX®2-73 (blarcamesine) over 5 years, however it is pleasing that physicians have requested extended treatment of their patients with ANAVEX®2-73 (blarcamesine) beyond these 5 years.”
The participants (physicians and patients) made the request to make this SAS approval possible, but it doesn't stop others from applying. In the past, the extensions were just announced as such..not as SAS. So, why this approval now and how is it different from other extensions?
The Special Access Scheme:
Most therapeutic goods are required to undergo an evaluation for quality, safety, and efficacy, and be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. In recognition that there are circumstances where patients need access to therapeutic goods that are not listed on the ARTG, the TGA facilitates a Special Access Scheme (SAS) for physicians seeking to use medicines that have not yet been approved in Australia. The SAS refers to arrangements, which provide for the supply of an unapproved therapeutic good for individual patients. Applications under the SAS are made to the TGA by their treating doctor, and approval to treat the patient takes into account the safety of the drug as well as supporting evidence that the drug may benefit the patients, along with the failure of any current therapies.1
So, with this SAS approval, physicians and doctors can get the medicine even though the medicine is not in ARTG
brichnyc, small correction (maybe big)....this is not just for the 32 participants....it is for all of their doctors can submit a request which I think they can do based on the info and results from the folks who got the access. Kind of getting personalized pass (personalized per patient....not doctor) for the drug use.
vg_future
Agreed and understood. It would have been great if there was more excitement. However, I was thinking the reaction from the CC was due to PDD readout statement.
boi568, agreed. I understand that it is an estimate, but I wanted to see/show the potential. The current market cap and the market reaction to the NEWS is pitiful. Hope it turns around soon.
-vg_future
Double-Trouble, you mean why wouldn't he....one thing I can see is that he has been excited for sometime now (I don't know about today) and then we have people jump at that and say any CEO would speak like that...there is no winning. The point is CEO alone shouting wouldn't count in the market....someone outside...like analysts should start shouting/screaming with excitement.
Wow! Wouldn't that be around 1.5 bill per year just by taking 300K patients for Australia alone? We are down because we got an unexpected BMW delivery while we are waiting for a Mercedes (which BTW is still on its way for delivery....not cancelled). I am hoping some analyst would see this and is going shout it from the rooftop....or some pharma will smell this out and come to partner.
-vg_future
Thanks guys. This is what we should take and talk about.....excellent NEWS. Feel bad that it has been downplayed heavily. A big official vouching from the regulatory board for the drug....relief for patients and investors.
-vg_future