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Accelerated approval reforms make the cut in year-end government spending bill
Zachary Brennan
Senior Editor
Congressional negotiators have decided to include reforms to the FDA’s accelerated approval pathway in its year-end spending package after the agency’s top leaders called for tighter controls on confirmatory trials and an easier process for withdrawing dangling accelerated approvals that failed their confirmatory trials.
The text of the bill, known as the omnibus, had been floated earlier this summer but it was unclear what it might attach to. Now, the AA reforms, released late last night, appear to be ready for showtime, stipulating that moving forward, FDA “may require, as appropriate, a [confirmatory] study or studies to be underway prior to approval, or within a specified time period after the date of approval.”
Oh, it was great. I basically said F you and we will cover whoever we want to cover.
Here is my message to the AA and their response.
I would like to understand why the Alzheimer’s Association has not followed Anavex Life Sciences who has recently shown tremendous P3 results that are improving patients after 48 weeks on the drug with very limited or no adverse effects. This small company needs your help as they are the only company who has shown real improvement for early Alzheimer’s and Parkinson’s dementia. Please take a look at them and help them get this drug through the FDA. Thank you.
Good morning,
Thank you for reaching out to ALZConnected. It's terrific to hear how passionate you are for Alzheimer's disease research. We very much appreciate your feedback and recommend that you keep an eye on alz.org/news for announcements.
I did want to let you know that the Alzheimer's Association works with many organizations in the field of research and clinical trials, including Anavex. You can find out more about our clinical trials through Trial Match.
Thank you so much and have a terrific holiday.
Sincerely,
T. J.
Boy, this really is a tough crowd. I get my balls busted for suggesting a little bit more marketing and suddenly I’m a loser who should sell my shares. I’ve been here just as long as anybody else with probably more shares than 95% of the people on this board. I’m going nowhere and I will continue to suggest. What happened to free speech? Btw everything I say on this board I have relayed to the company as well. Oh, and by the way, they tell me this is coming sooner rather than later, meaning the marketing side of things. As a matter fact, they’ve already been interviewing for this position. I just wish it would happen quicker. It might’ve happened already and we don’t know it. And no I do not want us to act like BIIB. But when you have the goods say it loud and proud. So nidan and Hoskuld, I respect your comments most of the time, but this one I do not.
Or it comes with a great marketing team. They build relationships with the press who will publish news that has impact. We do not have a marketing team. We have a control freak of a ceo who must let others do the marketing/sales. It’s time to bring these guys on board. If we think Rett will be gaining approval by eoy 2023 we need people up to speed and running by q3. Hire them in q1 but get the marketing leadership on board now.
By the way, I’m sure most long-term holders on this board have thought about this, but we’re afraid to say it out loud to anyone for fear of jinxing us. But if we did not hit our endpoints and Dr M came out with his PR don’t y’all think that we would have about 10 class action lawsuit against us? I haven’t seen any and I don’t think I have the power to make it happen just for mentioning it. We got this!!
From one of our SAB
https://link.springer.com/article/10.14283/jpad.2022.103
This is important. Watch the whole video but the interesting part starts at the 2 min 40 sec mark.
Here is our new hire for Regulatory Affairs . He is a big hitter. That seems positive doesn't it??
https://www.linkedin.com/in/david-goldberger-2439a14/details/experience/
I think you design a 30 mg arm because Dr. Missling is counting on that dosage being used potentially prophylactically. Just think if your susceptible to Alzheimer’s disease at say age 40 you start taking a lower dose 30mg or lower you stave off Alzheimer’s. That to me is the potential reason.
Is it possible that the FDA and Anavex have discussed the 30 mg and 50 mg separate trials and they can standalone. Yes they did pool the data to release the information they released but maybe there has been an agreement with the FDA that if either one or both trials pass they will approve. So if the 30 fails and the 50 passes we still get approval for the 50.
So my big question would be if they choose to do the odds ratio why not come out emphatically and say we did this to have a better comparison to Biogen and we will give all the other data when we finish analyzing. If they came out and said that right up front and again, I’ll repeat emphatically we probably wouldn’t have the downturn that we have. Yes, of course the shorts will attack but everybody can go and point to the fact that they did this purposely, and are not trying to hide anything. how about use those specific words. That we are not trying to hide anything. We met all our end points and all the data will be coming out soon and we did this this way to compare and contrast versus Biogen. When you are changing the rules that people expect, you have to explain it clear and very loud. We saw what happened with the Rett data. This is why we need a VP of marketing that can take these presentations and say it clearly and concisely and emphatically. Along with the benefits of doing it? Do not leave anything to interpretation
Mayo, why don't you take your research report and get it out to the masses. I'm not a big fan of Seeking Alpha but that could be one avenue or open up your site to the masses. Just thinking this might be a good avenue to combat the hit pieces that are running around since we cannot count on the company to get the messaging correct. Someone I recently spoke to had a conversation with the company and they said that the data is actually better than they expected. I'm not technical enough to present this and I know that your work and conversations with MacFarland adds credence to your report. Thanks for your consideration in getting this out.
If I had to guess what is going to happen next is with the current P2/3 data set which has met its primary and secondary endpoints I would do the following: I would take that data and package it up for an NDA with Accelerated Approval, in ALL the country agencies ( FDA, TGA, EMA, etc. ). I would include within the NDA all the data from the previous PDD and Alz trials along with all the OLE data. That OLE data has been promised this month as you recall. I will make the assumption that we will get that as promised. If they can get the NDA out before the end of the year or Jan/Feb of next year and they announce it, the stock will skyrocket. Once the agencies accept the documents for review the stock will rocket some more. Not sure how long they have to either accept or deny such a request but regardless just the submission and there is only one way to go, and that is up. Follow that up with Rett P3 data and soon to follow Accelerated Approval for that NDA submission and now we are really cranking. Hopefully we get Rett approval first to collect the voucher and we use that to further expedite the Alz NDA. Maybe just maybe we have both indications on the market before the end of the year or Q1 worst case. Am I dreaming??
Personally i think a $5M share buyback is a start. Get on board with Wall St. by doing a secondary say for 25M shares at $10 to the top 10 or 20 institutions. That would be about 2.5M shares for the top 10 or 1.250 for the top 20. Collect $250M and get Wall St on your side. I don't care about the dilution. I want the street on my side. The company did not got the route of IPO and Wall St. does not like that . A secondary can help eliminate that pain.
Also, have all senior management buy some shares on the open market. Something substantial, not 373 shares like before. I would also have Paul Aiesen and Jeffery Cummings come out and say something. They are on our Scientific Advisory Board yet we don't use them. They are KOL's for Alzheimer's. I thought we would have had a full blown marketing plan for this data release to include worldwide print and tv coverage. Who is calling on these people to discuss what we have done? Why aren't the top funds like Baker Bros not on board? Who is proactively calling on them? Get me a Wall St. friendly Sr. VP of Marketing on board NOW! That is who will call on them. That is my .02c. I am still bullish but we continue to have a strategy that allows the shorts, hedge funds, etc to play with us. Someone has to pound the table. I'm mad as hell and I'm not going to take it anymore.
Where are our big-name scientific advisors coming out and speaking about the unbelievable results we showed last Thursday night. Jeffrey, Cummings and Paul Aisen should be out there leading the charge.
Halted
Where are all the shares coming from without the price of being driven higher? Seems like the market makers are letting the shorts cover and just waiting for news tomorrow to rip it higher
Take a look at the January 45 strike for next January and you’ll see they are offering a $.70 premium right now. That to me smells like good news on the way that somebody is ready willing and able to offer you $.70. I can imagine if this stock runs to 30 to 40 those premiums will be in the $30 range at this time two weeks from now.
The put call ratio has been all over the place today. I’ve seen it over 4 and right now it’s sitting at 2.56. I guess people are loading up on puts to hedge their long bets.
What are you talking about Missling is being quiet? He just spoke at the Guggenheim conference and it was a tremendous presentation. That wasn’t that long ago.
How do you know that buyer sold?? Link please.
So Mayo, what other stocks to you follow and dive into like you have done with Anavex. It might be a great idea to piggy back on your work. With this crowd if we all find another great stock we can take it up for you and us. Thanks.
If you believe that part of Dr Missling strategy is delay and keep the competition/shorts off balance then why do you think he will come out with the data on the announced date of 12/1? That is keeping no one off balance. I would think if you want the largest impact of keeping people off balance announce the great data at 8:00pm on the Friday the 25th. Shorts have no way to cover, maybe we get upgrade over the weekend up to say $75pps - $100pps and we have a runaway gap up on Monday morning to $55-$60. Then we present data on 12/1. Great news is again needed and we run past $75 only to pull back to $55-$60 to let the remaining big guys add more. Remember all this is dependent on great data, kol’s on board. Fingers crossed.
Question for theboard. What happens if we hit our 2 primary endpoints on the AD trial and only one of the secondary endpoints, that being safety. What do we think the FDA or Australian ( FDA ) would do? The other secondary that I am speaking about is :
CDR-SB (Clinical Dementia Rating Scale Sum of Boxes) [ Time Frame: 48 weeks ]
Reduction in cognitive decline assessed from baseline over 48 weeks with ANAVEX2-73 compared with placebo using the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)
Any thoughts on what might happen as we approach the regulatory agencies?
Thanks
Not sue what you are seeing on the RSI. The 30 min chart shows an rsi of 67.7 , the 1 minute has us at 50.92 and the 1 year we are just 70. Far from over bought. We have a long way to go before we are over bought. Maybe at $20 we could be overbought but then we get news and this goes out the window. Hopefully a high class problem at $50 in a few weeks.
Interesting that all the other CNS plays like ANVS, AXSM, SAVA, are all negative or very slightly ahead, compared to Anavex up almost 15%. Maybe news is starting to slip out and shorts covering.
30 this is not a true binary event. We have a phase 3 rett trial that will read out in Q1. That will lead the way to the approval for both pediatric and adult Rett suffers. So again this is not a binary event. Two completely different indications.
https://fintel.io/so/us/avxl?d=2022-09-30
Early tutes coming in . Barclays adds 189K shares last quarter. A few new smaller ones as well.
not a chart reader but did we hit some technical level today at 12.70 that exasperated the selloff? Down .98c from high to low. Although we were ONLY down 5% on the day it was almost 10% from the highs.
strange that with the downturn due to the fed bs that dnli, anvs axsm biib acad have all stayed positive while we have dropped 3.25%. Even sava has come most of the way back after being down 12% earlier. what gives with that? I suspect that the MM's saw a path to grab some shares and are driving it down. hopefully by the end of the day we get back to even or close to it.
The stock will fly on good/great news. How high who knows but I think we will see 40-50-60. At that time we will see a pullback based on the big guys shorting it down so they can get in or acquire more. Maybe they take it back down to 30-40. Once you see them piling in that is when we go to 100+. Look for the big names like Baker Bros , Goldman, Morgan etc. When they drive it up to 40-60 sell short term covered calls. The premiums will be huge then you get the pullback. Keep your stock and premiums then let it run.
Here is the way I see some of these new hires. I don’t really care if they are young. As long as they are smart and can do the job they’re being hired for. To me they don’t need to be hiring these guys that have been in the industry for 20 years and used to making hundreds of thousands of dollars a year and demand huge stock incentives. Give me a young kid like this guy who can come in at a cheaper salary, maybe a decent size stock option program for them and let them run. Chances are the company is going to be sold off anyway in the next one to two years for $15 billion You don’t need bloated, payrolls and a huge staff that might not be needed by the acquiring company. Keep in mind Alzheimer’s will be partnered and we don’t need staff to handle that part of the job. We need people to handle the basics for the rare diseases that we will keep in house.
We have another new hire. Connor Peterson, Medical Director.
https://www.linkedin.com/in/connor-peterson-m-d-25b4b8103
I just received this from Dr. McFarland on linkedin. So no guarantee he is speaking. I'm sure it will be Chris. He is the CEO and if there is great news to spread he will be doing it.
Hi Steve. Just wondering if you will be doing the Anavex presentation at CTAD on December 1. I should be attending and wanted to hear the great potential top line data. Thanks and keep up the great work on behalf of all the Alzheimer’s patients.
Steve Macfarlane sent the following messages at 5:04 PM
View Steve’s profileSteve Macfarlane
Steve Macfarlane 5:04 PM
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Hi Rich, I always try to attend CTAD, and this year will be no exception. Exactly who will be presenting has not been determined yet. Cheers, Steve
So I just did an option trade and to me it seems a bit weird. I just sold the December 10 puts and receive $3.30. That seems like an awfully large premium unless of course the options gods know something is wrong and the stock is going to go down but doing this trade the breakeven is $6.70. Someone tell me what’s wrong with this picture.
Not sure why you would sell covered calls now and not wait until the stock runs and get a much larger premium at a strike price that is much higher where you really should be able to keep the stock. For example if the stock goes up to say 35, sell some Jan 45’s and collect the larger premium.
From stock twits. BI Research write up.
https://stocktwits.com/marregi/message/491020840