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Haven't had the chance to look at the CTAD release closely yet. I saw that extension study (post-52 week) data is released! Is the actual data out? A graph -- anything? Or just the text from the release saying that decline of MMSE, etc. was stopped. Thanks!
If you have some information that refutes that, it shouldn't be that hard to dig up... Your response is unhelpful.
I would like to see references for that. Per these studies, donepezil results usually in a slight decline in MMSE at about 12 months, which is the same as what 2-73 accomplished for the average of all patients in the 52 (57) week results. And it performs better than placebo in that time frame.
https://www.medscape.org/viewarticle/481063_5
https://www.medscape.com/viewarticle/507510_3
https://www.researchgate.net/publication/6494106_Donepezil_in_Alzheimer's_Disease_What_to_Expect_after_3_Years_of_Treatment_in_a_Routine_Clinical_Setting
I agree with you. Even if 2-73 just has the same efficacy (on the MMSE chart at 1 1/2 years and onwards; it probably has other indications) as donepezil, it will still be a better drug because it looks to be much better in terms of adverse side effects. But if it leads to a relatively stable, or much slower decline in MMSE at 1 1/2 years and onwards, then that is a potential complete game changer (will be easier to gain market, make really big money, etc.). Whereas, if it has a similar effect (like I said, just in AD, not including other possible indications), it will likely gain market much more slowly, even if it is a better drug in terms of side effects.
So I'd really like to see the MMSE chart extended to 18 and 24 months per the extension study they've already completed.
I'd like to see charts/studies. That's not what I've found. What I've seen is stable or very slight decline at 12 months, which is the same as 2-73 at 12 months.
These for instance:
https://www.medscape.org/viewarticle/481063_5
https://www.medscape.com/viewarticle/507510_3
https://www.researchgate.net/publication/6494106_Donepezil_in_Alzheimer's_Disease_What_to_Expect_after_3_Years_of_Treatment_in_a_Routine_Clinical_Setting
Yes, but he said "new data of population PK/PD," which I found mildly disheartening. There was no mention of the 104 week data. Maybe this could be included under new data of PD? But why wouldn't he just say new data of the "extension study" or the "104 week." That seems natural to say, if it were the case.
Patients on donepezil improve or are stable for about a year. After that, the decline begins. That's why I really want to see the 104 week extension data -- for the MMSE in particular, to compare. The 104 weeks was complete a while ago, right?
If you're referring to slide 17 of the 2016 CTAD presentation http://www.anavex.com/my_uploads/CTAD-Anavex-December-2016.pdf, 5 patients were lost by the time Part A (5 weeks) was completed. There is no useful data from that. 2 were lost halfway through Part B. Maybe their results weren't great, and could be included, but it doesn't seem untoward to exclude dropouts halfway through the 52 weeks since their progress couldn't be represented. Your comment that 6 were "purposefully omitted" seems unfounded.
What I want to see is an MMSE chart for the different doses over the entire two years (including 52 week extension). If MMSE didn't substantially drop from 18-24 months, that will be a big difference from donepezil, and would be very big.
Questions re dosages and the extension:
1. Do we know how many people were on each dose?
2. Has the extension completed? On clinical trials it says the extension started in March 2016 so seems it should have?
I haven't looked closely at this. But where are you getting the "6 patients they purposely omitted"? That just seems out of left field. What evidence do you have for that?
I'm confused. Where are you getting the MMSE data for just strong responders and the weaker responders, lower doses, etc? All I've seen is the MMSE chart for all patients on slide 29 of that CTAD 2016 presentation. Are you taking the strong responders from slide 31 of that presentation? But it doesn't say anything about doses right? Some of the "strong" patients could have even been on lower doses.
I answered my own question. On the majority of the charts, it was weeks not months... Dumb. Time to go to sleep.
I did find one chart showing an improved MMSE on donepezil over one year as opposed to a slight decline. Here: http://www.medscape.com/viewarticle/507510_3. That was just one study though with a similarly small subject size. It still shows the big decline at 18 months and on.
Right now, the MMSE chart for 2-73 pretty much looks like most of the ones for donepezil. If 2-73 shows a stabilization of the MMSE past one year and to two years that would be huge, so I'll be looking for that.
I'll leave up the previous somewhat dumb concern because maybe it will still be helpful to some people re the MMSE chart.
So, a scientific/trial result question -- I was going over this, more closely than before, which I should have done already:
http://www.anavex.com/my_uploads/CTAD-Anavex-December-2016.pdf
On slide 29, it shows MMSE and ACDS-ADL still declined slightly on 2-73 over 57 weeks. I looked up donepezil on MMSE and found charts that showed MMSE improved slightly over 52 weeks. It ended up declining from the initial point around 2 or 3 years.
This is one concern though, as I had thought 2-73 was (so far) superior to donepezil in each measurement. But based on just this little measurement it seems inferior, at least at 52 weeks. It could be better at longer periods, but those haven't been shown.
Also confused because the next slide says it was better than the SoC on MMSE and ACDS-ADL, and the control was an acetylcholinesterase medication or memantine but I guess based on the charts I looked at the medication was not donepezil?
Anyone have insight on this? Thanks.
I’ve been out of the game for a bit. Anyone have a quick summary of upcoming potential announcements/conferences etc?
Wait, is that true? 2-73, by itself, doesn't have patent protection? If so, how did I miss that..
I'm extremely sorry for your loss, but we're talking about statistics. Evidently, the FDA thinks that CAR-T is worth the risk. If 1 person dies but 10 live because of a drug, is it worth it? How about 100? My point is simply that at some point it appears worth it.
That does not take away from the tragedy of someone dying because of a drug.
Shares in a BO company is not what I want. You will never get the same return in a $100 billion cap company as you could see in a company this size. I hope that AVXL contracts for manufacturing and distribution, rather than partners in any way that dilutes its autonomy.
Say the stock is $35+ around approval. An offer is made for $50/share. Missling has a little over 1,000,000 shares. That's $50 million. How many shares does Skarpelos have? I assume more, so north of that. I'm sure Missling has plenty of options as well.
I don't regard that as "on the cheap."
I do agree that there are some clear differences with KITE, but institutional ownership could change very quickly. If there is sustained good news, don't you think institutions would start taking much bigger positions in AVXL?
I'm not trying to throw in red herrings. Perhaps the Board is heavily committed in taking AVXL, on its own, to being a big cap pharma. I certainly hope so. I am invested in AVXL.
I think some of the people here estimating massive potential returns based on huge revenues at some point in the future, based on the many possible applications of the drug apart from the big one of Alzheimer's, are forgetting a key possibility. If 2-73 does show good results and gets near or just post-approval, it would be very unsurprising if a larger pharma bought AVXL out.
AVXL is a tiny company, and dealing with rollout of a massive, blockbuster drug could be difficult, even for one that is administered simply. And if 2-73 were approved, the stock price would likely be at least $30. A buyout would add probably 30% value to that. Do you think the Board would turn down such an offer? They want to cash in, and get out from the risk. What does it matter that the company could be worth many billions if they didn't sell? They'll all, including Missling, be stupendously rich after a buyout.
The same thing happened with another pharma I own today, KITE. Though I was invested, I am not happy at the 30% return today, because that's the end of the road. I'm not going to invest in Gilead, because it's a $100 billion cap company. I understand why the Board did it. Many people would have revolted if they didn't sell for a 30% premium. But I am not happy, as I wanted to ride KITE for years in the future, and, I think, to much larger values than $180/share.
The same could very easily happen to AVXL if 2-73 is approved or looks to be approved in the future. It's probably more likely than not. Annoying, but true.