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Just a reminder, these positions have been out there on their website for the better part of the last year. If you check on LinkedIn, the number of employees sets at 40 and it has been in that area for the better part of the last year as well.
All that seems to be very true. But one of the things that you are missing on is that although it is not data release, he has not started as far as we know any of the new trails that should be going and they were all to have happen before the end of last year. So right now, the new rare disease that we don’t know what it is yet is about eight months late along with the Parkinson’s trial , schizophrenia trial frontal lobe dementia I believe for 371 and anything else that out there. He has missed a lot with no explanations ever.
The question is how has the stock performed since insider buys not how has the stock performed since it’s lows. Since insider buying took place the last three or four purchases are all underwater. Most of the shares purchased in the $25-$26.area. Get your facts and banter straight.
And exactly what did the share price do after the Sava insider buys? It might’ve had a pop on the day, but since then it’s been down.
Sarapta just sold today their priority review voucher for 102 million dollars
I’ve noticed Prothena on Twitter a lot lately with videos, talking about mis-folded, proteins, and treating CNS diseases. Sure wish we would do things like this.
Yes but 4m shares traded hands. Either way we had some big guys entering and maybe some shorts exiting. I think this is a good sign.
How about a simple answer. They drove the price up because there just wasn’t enough shares for them to steal at lower levels. Once they got it up they brought it down and stole a few million shares all in a very short time.
On LinkedIn new head of r & d position is open. Did we have on of those already. Sorry I can’t cut and paste it.
So can someone help explain something to me as a layman. With all the trials that we have completed for Alzheimer’s along with the success we have had with our primary and secondary endpoints, we are now looking for approval based on “other endpoints “ or biomarkers . That being the success of reducing the abeta and tau in the brain as well as or better than Biogen and Lilly.
Does that mean that our endpoints don’t matter anymore or just an added benefit that we improve cognitive performance? Do we have to be better than what is now approved with reducing abeta and tau or just close to them because we are just a pill and we don’t require an infusion every 2 weeks? It seems weird to me if this is accurate that we can get approval based on this rather than all the great results we have had on cognition and all the other side benefits of Blarcamisine.
Just because those positions are still sitting out there as open on the website doesn’t mean they are. They are very slow to update their website. I’m sure they’ve hired at least a half a dozen people on that list. I know they are interviewing like crazy.
Just remember that Wall Street is a mechanism for transferring wealth from the impatient to the patient.
It would really be nice if he did answer but I’m not expecting answers to all of them. I would like to hear about his body language and what he does say about them. A lot can be heard and seen without getting the answers.
Some potential questions for those going to the ASM tomorrow. I will not be able to attend.
1. Given the overall success of the pipeline and zero failed trials to date, why hasn't Wall St. given the company a proper valuation and why hasn't the true biotech institutional investors shared your excitement and bought shares of the company?
2. Can you please explain why you did not go for approval for Rett adult population which basically slowed down the time to market by over a year having to wait for the pediatric study to end. Why didn't you complete both trials at the same time? If this took place the drug might be on the market today.
3. Can you please let us know if the confirmatory trial being run for Alzheimer's will be a P3 placebo trial or a P4 trial with no placebo?
4. The surrogate biomarkers that the company is trying to gain accelerated approval for is A-Beta and Tau. Did we remove this plaque at the same levels that Biogen and Lilly reported. Is Blarcamisine more effective than their drugs in doing this?
5. When will you be meeting with the FDA and the other agencies around the world to discuss Accelerated Approval?
6. In what timeframe to you envision an NDA to any agency for approval of Blarcamisine? Since you stated that you are ready for commercialization how far down the path is the company with gaining approvals knowing that Accelerated Approval allows for more meetings and submission of data as you receive it instead of waiting for all data to be packaged? Are you weeks away from submission, months of an NDA for any region?
7. Why take the strategy of promising a lot but not delivering in a timely fashion? The company never hits its self imposed timeframes.
8. What do you envision the headcount to be by the end of the year and if things go as planned where do you see headcount end of next year?
9. Why no insider purchases to help protect the stock and shareholders?
10. What is the status of partnering? If you are approved for Accelerated Approval I would think that a partner would need to be completed soon. Do you see a partnership this year?
By the way, our senior vice president of regulatory affairs worked at this company prior to coming to Anavex eight months ago The company is Otsuka from Japan. I believe that they are approximately a $3B company.
https://www.nwasset.com/ These guys just took a new position in Anavex. To the tune of 548K shares. We are now up to 37% institutional ownership with Monday being the final day to report.
https://www.nwasset.com/ These guys just took a new position in Anavex. To the tune of 548K shares. We are now up to 37% institutional ownership with Monday being the final day to report.
A few questions for the board.
Is what the company company saying regarding the surrogate biomarkers is that 2-73 is eliminating the A Beta And Tau plaque to the same extent as Biogen or Lilly and thus please grant us Accelerated Approval and we will commit to do a P4 trial? Oh BTW we actually reverse or halt the progression of Alzheimer's Disease in a good chunk of patients with little to no side effects?
Is this being considered because of the guidance from the FDA or just guidance from our internal people that came from the FDA?
Will the Alzheimer's OLE extension trial be considered by the FDA as the confirmatory trial?
Thank you.
Keep in mind, if they are going to be doing a confirmatory P4 trial in AD I would assume our partner will be running it. Can someone say Partner Announcement soon??
So maybe what we are reading is that they have had discussions with the FDA or other agencies and they guided to a P4 confirmatory trial. and once they have the full data set ready for discussions with regulatory agencies, they will look for Accelerated Approval Pathway.
I listened to it twice and wrote it down when I first heard it. I believe others have heard it as well when he made the statement and it was discussed here as well.
A few days ago Dr. Missling spoke at a conference and stated, and I quote “ we are ready for commercialization, we are very close to commercialization “. If I were one of the special few who will be allowed to ask a question on the upcoming earnings call I would ask the following.
1. Can you be more specific on these statements?
2. What are the remaining steps that need to be accomplished in order for approval to happen and the actual product being allowed to hit the market? Please be specific.
3. Do you see Rett coming first or Alzheimer’s?
4. Where will commercialization happen first, in the USA , Australia or Europe?
I believe you are way off base. I think Top Line data before the end of June 2023. This was a small trial so it should go much faster. No reason they cannot get an NDA filed by the EOY with the FDA accepting the NDA within 60 days and decision could be by July 2024 or sooner.
"assuming the Excellence study had LPLV last week or this week and it clearly succeeds and if Missling can keep to a reasonable timeline, topline will be September 2023, submission April 2024, filing of NDA June 2024 and decision December 2024. They might shave one month off this but could also miss by a month or two to the long side."
I will not be able to attend the shareholders meeting but I do have a few question I would like answered if someone who is attending can ask please.
1. To Dr. Missling: You have been mentioning lately that the company is preparing for commercialization, what exactly has been done to accomplish this?
2. You currently have only 37 people on board, what are the plans for hiring knowing that Rett and Alz approvals are coming soon. What will the headcount be by the EOY and the end of next year?
3. Why has it been so challenging to hit your self imposed deadlines and milestones over the years?
4. What countries will you target first to seek approval once you have the full data set complete and ready to submit for both Rett and Alz? Will Australia come first or will you always seek approval through the FDA first and then move to other countries?
5. Do you have multiple manufacturing partners lined up to produce Blarcamisine?
6. When can we expect the all important peer reviews for Alz P3 results?
7. When do you envision hiring a VP of Sales and Marketing?
8. What changed within the company that made you bring on Dr. Ma as Chairman now?
9. Why do you think the company has not gained the support of Wall Street or the scientific community with the fantastic data to date? Biogen or Lilly go up $20B in market cap on their data and we go down with ours. Any thoughts on this phenomenon?
10. You have always said that the company will need to partner for the large indications like Alz and Parkinson's, do you still feel that way or would you be open to a buyout if the price is right? What is the right price?
Thank you.
Has anyone spoke to the Clint or IR about the commercialization comments and what that really means? I’ve tried but getting no response. Thanks
I say we get excellence results, late May early June, which will be spectacular then in July we present for Alzheimer’s results at the big conference
Ready for commercialization, very close to commercialization !! Statement from todays conf call.
What oversight? Ma is an insider picked by Missling to be on the board then bumped up to chairwoman. Not much will change. If you think they will communicate better forget it. Business as usual. She will help with partnering or acquisitions. They will all line their pockets with more $$$ and stock.
You make some great points. I hear you and agree. I also think we should have done a deal with a big Wall Street firm to put us on the map and show we are friendly to the street instead of the one we did with lpc.
Why do you think we need a partner before we go to the fda?? I'm not so sure that is needed. What if they wanted to go it alone? The fda is all about drug approval and making sure that your manufacturing is up to speed. I do think we partner sooner rather than later but not so sure it needs to be before we go to the fda. I'm thinking we partner in the June / July timeframe and we get accelerated approval for AD with approval coming in Q1 2024. Rett approval should be by the end of the year or Q1 as well. I'm hoping anyway
Mis folded proteins are the new bio marker per the MJFF. Exactly what we fix.
So tell me, why hasn’t any of the insiders sold any of their shares in the last couple of years. Missling has about 8M shares and should be selling along the way to protect himself. Why hasn’t he??? If what you say is true they would not be in hiring mode. They would be laying off people.
Yes. I also said at much higher prices. Like $30pps. I’m just not sure what you’re doing talking shix about the company ALL the time. What is the point?
Great job talking your investment down. I just listened and he sounded like he always does. If I were you I would sell.