I'm always hopeful in all these alternative plays as the SOC plaque attack drugs aren't worth the money
Thanks, they are really hopeful since
Buntanetap is the only drug to attack multiple neurotoxic proteins.
Best wishes to you.
I had researched them in the past. In theory I liked their story about synaptic health and how the drug potentially worked. Preclinical it had a secondary impact on PKCe and Hgf and as you know, this is something I have researched. When I looked at details of how they were running their clinical trials I had concerns about the memantine free period before dosing so have never bought in. I still think they have a shot but maybe longer than I first thought. Of course at current prices it may be a better gamble than in the past.
I still follow the sector but I'm just not seeing a revolutionary treatment at this time. Doesn't mean none of these will have limited success, or potential approvals in some groups, or nice sales, or even make shareholders good money. I've been hoping for a true game changer and I don't currently see one. JMHO
Have you looked at Annovis bio?
Quite a swing
I have no idea. With approval comes reality.
The stock changes from a speculative play to a revenue generator.
Earnings, expenses, partnerships and buyouts are all on the table.
Yeah it's hard to wait them out. Looks like 12-15 months
Thanks. I got burned on SNPX, so gonna wait this one out.
How long is this study?
Thanks for posting the CTAD slide link
There is also a youtube video of the presentation. Since the stats were standard (not requiring a statistician to explain), a presentation by a clinician may have been better. Platform sessions are always difficult as one usually has 10-12 minutes to present followed by 3 minutes of Q/A. Therefore a lot gets glossed over.
Data out to 18 months is very useful but until the large P3s come out we have more questions than answers. I'll add a few thoughts/comments (I will probably end up annoying both the longs and the shorts)
The study presented has an unusual protocol. All 216 patients received simufilam x 12 months. The 157 patients remaining were then split to receive simufilam OR placebo for the next 6 months. 133 of these patients were available for 18 month analysis. Patients were evaluated as the entire population (2 groups - 12 month simu/6 mo placebo vs 18 month simuilam) or further split into mild and moderate to 4 smaller groups (mild 12/6, mild 18, mod 12/6 and mod 18). All remaining patients are eligible for 6 more months simufilam. The thought is that if simufilam is a symptomatic drug, the M12-M18 placebo patients will lose ground to the patients on drug the whole 18 months. If simufilam is disease modifying they won't lose ground.
To me, the data that is most favorable is that the MILD patients were stable the whole 18 months - about 1/2 would have improved the ADAS-Cog score. Obvious caveats include open label, small n, were patients going downhill withdrawing more than the stable patients, etc. Additionally, the entry criteria did not require proof of amyloid --- meaning about 20-25% of patients may not have had AD. AF jumped on this fact. Highlighting the issue (slide 17) is that the mild patients included patients with normal MMSE (27-30) and normal ADAS-Cog (0-10).
Moderate patients did not fare as well. They may have done a little better than historical but by the time you throw in open label (matters less in mod than mild), small n, entry criteria, etc no conclusion about efficacy in this population is possible. That's ok - the new anti-amyloid mAbs are approved only for amyloid proven MCI and Mild AD. What troubles me is that the moderate population is included in the 2 Phase 3's and potentially could dilute efficacy data. My hope would be that the SAP has been changed to put mild amyloid positive patients at the top of the statistical hierarchy and total population further down. If indeed this change has been made, they need to be clear now to avoid claims of cherry picking after the P3s are analyzed.
I think the n is too small and entry criteria too liberal to determine whether a disease modifying effect has actually occurred - In reality this is very difficult to prove.
As far as AF, I think pointing out the issues with the entry criteria is valid. However, his calls to stop the P3 studies due to this issue and Dr. Wang are silly and hurts his credibility. If anything the results presented offer just enough hint of efficacy to add more excitement to the P3 results to be presented at the end of 2024. Also note that the P3s have an SPA with the FDA, have standard proof of amyloid entry criteria, standard endpoints, have large n and reasonable duration (one is 12 months and one is 18 months). I would have preferred ADAS-13 over -12 as slightly better in the mild AD population.
Educational note about ADAS-Cog: This test has gone through multiple revisions with most recent ones trying to improve sensitivity to measure change over time in MCI/mild patients. All revisions are downward compatible (you can derive ADAS-Cog 11 from -13 as the difference is 2 additional tests). Adas-Cog-11 has a range of 0-70, ADAS-Cog 12 a range 0-80 and ADAS-Cog 13 a range 0-85a and ADASCog 14 is range 0-90. The additional 'points' are more sensitive to MCI and Mild AD change over time. This is one reason why entry ADAS-Cog differs from study to study (i.e in the simufilam P2 mild average aDAS-Cog11 was 11 and in the AVXL study entry average was 29 on Adas-Cog13 and lecanemab was 24 on the Adas-Cog 14)
Is the powers to be readying his stock for another secondary offering or are they prepping the price for a buyout incase the unblinded TLR data comes in successful?
Whoever it is doing the “tankdown” they are very patient and coordinated as they have dropped the whole sector.
Yes I saw that - excellent presentation. The numbers seem pretty terrible though.
The separations between placebo and drug groups for mild (especially) and for moderate were very small. Let’s hope the P3 trials with their much higher N’s and longer duration will show both separation and stat sig. The presentation was largely marketing but the numbers themselves were not great.
Of course it is and most DON'T know it. It's also beneficial when recruiting for these trials as well. Evidently the market thought it was important as well, even if most of those on this board knew it already.
re. "One would expect that aria would only be an issue for mAbs."
For a patient or a caregiver, this is good to know, don't you think?
It doesn't really. You could claim carrots don't cause safety issues...but they are not proven to help slow dementia, either. The ARIA issue was a silly one to highlight. But, it wasn't bad news at any rate.
It certainly differentiates it in the safety department from any approved drug. Not everyone understands the MOAs of each of the drugs but knowing its safe is important to most. Nice 50% bump of the bottom! Probably not going to be greedy here
One would expect that aria would only be an issue for mAbs. This is kind of like having a house painted white and pointing out that it isn’t red.
I think it will go down below 10 soon
Thats why I almost bought back in for a quick trade before the bounce back above 12. You have to figure more insider purchases on the way but price has to be lower than 12 for me. Jmho
Never been sure what to make out of the accusations from preclinical the work. Not sure why some have been so nervous about allowing the trials to move forward. Very fortunate it would seem that the trials are as far along as they are. I've been hesitant to tie money up as I figure they will eaise funds before results but I'll consider gambling if it dips under 10. Results being 15 months away doesn't help though.
Holy crap. Guess so
You don't know what it means because I think you may not understand how cheap some purchased this stock. Your post makes no since. Folks could have bought this hand over fist below 2 bucks. I didn't get quite that cheap. Quite that is and yes multiple times I have 20 bagged or more these stocks. It's all public record. I've also lost before too. I don't pretend to be a bio executive, nor accuse others to be something they are not.
Don't know what that means. This equity is trading under its IPO price. Are you saying that you once bought a life sciences company and made 20x? Maybe, but you are acting like an unbalanced pumper on this board so it seems unlikely.
Sure. Only 20 bagged this one. Try again