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That is what I said. He knows more than you. Why would I trust you above him?? He has all the info and you have nothing more than anyone else here. Maybe less than most here.
He said possibly we could see data this year. I thought (in my severely limited knowledge) that he was cutting it very close when he said that.
But what it tells me is that Dr Missling thinks they can start the trial, finish it, and have data prepared for release in about a 6-month time period. So whenever it starts, I'm anticipating data about 6 months later. Your "facts" can never trump what Missling says.
Anyone who puts more weight on an outsiders viewpoint is foolish.
IMO.
We will see Rett trial start before end of Sept IMO.
It will take about a month or two to fully enroll AT MOST. It may be fully enrolled from the start.
Trial is 3 months. That means all data will be in hand by Feb 2018 at the absolute latest.
Figure a month or two to prepare the data. We should see the results no later than April of 2018.
You are right.
Enrollment should take a couple months at most. That is going by Missling's now impossible (IMO) hope (as of a couple months ago) that Rett data could be out this year.
I think Dr Missling knows so much more about it than you. He said he thought that Rett data could possibly be out this year (which I doubt now). Even so, he obviously feels it will not take more than a couple months to fully enroll.
I take his opinion over yours every time.
It's a good thing that the company is going to put out all of this info in the next few weeks. It makes sense for them to release PK/PD in combination with...
patent announcement...
Trial structure...
trial starts...
MTA results...
I think people may be creating a straw man argument when they assert that results are "delayed". There is no factual basis for that opinion. Just because something doesn't happen according to your own timeline does not mean it is delayed.
The reasons for the timeline being what it is will become clear as these ground-shaking catalysts occur.
If you haven't seen it, PBS's documentary about AD is well worth a look.
http://www.pbs.org/wgbh/nova/body/alzheimers-be-stopped.html
Maybe he's signaling $750/share.
It sounds like they are talking about more than just AVXL when they say there are 160 girls in "VARIOUS clinical trials."
Right now AVXL doesn't have any girls in clinical trials. These 160 May be other drugs in development right now?
Manipulators are toying with the price. It's delusional to think otherwise. But I agree that the only reason they are able to have such success in moving the price where they want is because 2-73 (and AVXL's entire approach for that matter) have not been confirmed or validated. That will happen very soon.
All we would need to set this whole thing off is the slightest acknowledgement from a big bio like BIIB. An eyebrow raise or a nod in an interview discussing the MTA would set the whole thing in motion.
We are still waiting for 57-week PK/PD data. This is supposed to be released first, before any trials start.
Lots of things going to happen almost at the same time. Absolute powder keg.
Anemic volume recently. Manipulators are backing away from this one.
Ha! What a short pipe dream!!
If you are wondering how to find the patent info...
Go to this website
https://portal.uspto.gov/pair/PublicPair
Search for this "Control Number".
13/940352
Good information there. Especially in the "Transaction History" tab.
Nothing will stop it at this point. I surmise that we will see the final final update on the USPTO website around Sept 1.
Another step closer on the patent this morning...
08-17-2017 Email Notification
We should see a couple more entries noted on this patent before we should expect any announcements from the company about it.
This is what to look for:
1) Dispatch to FDC (already done!)
2) Issue Notification Mailed (already done!)
3) Email Notification (probably will see this in the next day or two)
4) Recordation of Patent Grant Mailed
And...
5) Patent Issue Date Used in PTA Calculation
(I'd look for these last two entries in about two weeks)
Once these are completed it is a done deal. Of course, it's already a sure thing. Just have to cross all the "t's".
With all the talk about patents, I'm wondering if anyone knows what exactly Patent Number 9,169,237 is for? How is it different from the one that is coming in the next couple of weeks?
Selling out now is asinine. Partnering...MAYBE, but it would have to be one sweet deal to be worth it.
Keep it all in-house for now. Waiting (even if it's just 6 months) will increase the sellout price dramatically.
Sorry. You responded to my request with exactly the thing I said was not evidence. Still waiting.
I already gave you the positive proof in my previous posts.
You keep repeating the same thing over and over with zero logic supporting your point of view.
Please state one shred of evidence to support the "bad news" theory? (And the lack of communication doesn't support it by the way) All you say is "it's a possibility".
Everyone here agrees that it is a possibility, but all the evidence seems to suggest otherwise.
If Biogen doesn't like it why the heck would anyone else think about buying into it? The first question a potential investor would have is "Why wasn't Biogen interested?"
That was the risk with the MTA for AVXL. If BIIB was unimpressed it would basically crush its future for partnering for MS, not to mention bringing lots more doubt into the picture for 2-73 in general.
If the MTA was fruitless we are in HUGE trouble. But since every single communication and planned step coming up is positive, you have to think the news is good.
Either that, or you think the company is being dishonest about how things are going. If you feel that way close your position. If you trust what they're saying then you have to believe the MTA brought good results.
We're obviously speculating here. You are speculating too.
Zero doubt in my mind that there will positively be an announcement of some kind regarding either continuing with the MTA or ending it.
Anavex would not put themselves in the position of trying to shop for MS partners if it is going to be public that BIIB thinks it is useless. Therefore, the MTA results are good.
This is not a stretch. It's sound reasoning based on solid evidence. Someone else might want to "wait and see" what eventually happens...what becomes a "known". That's fine. I will sell them some of my shares that morning for $70/share.
No announcement of BIIB dropping out is not a possibility IMO.
If their MTA was announced publicly, the ending of it would be public as well. Especially since BIIB is not going to be "ok" with tiny AVXL seeming to have some kind of connection with them if they think there's no value in 2-73. Why would they allow AVXL to be tied to them publicly if they really aren't.
Besides these things, the PR about the MTA said:
"A satisfactory result from the OPC assay study may lead to an in vivo remyelination study using a chemical demyelination model."
It was implied that this could lead to further collaboration. AVXL and BIIB shareholders will know when and if the collaboration continues to further steps, or if it ends.
Not likely at all IMO.
If AVXL knew that BIIB was not interested in pursuing 2-73 for MS why would they start taking now about developing it for MS?
They would look like fools (if this scenario actually happened...but it won't) when the inevitable PR is released saying BIIB was not continuing with 2-73 because they weren't impressed with their own testing.
Much more likely that BIIB is happy with their findings in the MTA and they want to pursue 2-73 and continue dealings with AVXL.
Well... in my version of a perfect world it could happen! Oh well...
What do you mean? The patent was definitely rejected back in March. But then in April they requested "After Final Consideration". Then it ended up being granted.
How about this scenario:
The patent is rejected 3/28/17
AVXL receives great results from BIIB's MTA. Talks with BIIB bear fruit and a plan is hatched.
AVXL requests re-consideration of the patent with expanded use in MS in combination with BIIB's drug.
Patent is approved around Sept 1st.
AVXL/BIIB partnership is announced Sept 11th.
They aren't using it in patients. They are only testing it on cells in vitro.
Let's walk through it...
In Sept '16 BIIB/AVXL announced a MTA regarding MS. A PR was put out publicizing the deal.
It has (IMO) been quite long enough for BIIB to have come to a conclusion about whether or not they want to pursue 2-73.
If BIIB has gotten results AVXL should be privy to their leanings.
Now... we hear that on Sept 11 AVXL will present a discussion about 2-73. The abstract for this meeting says, in part:
"The scientific rationale, preclinical data, and clinical development path of ANAVEX 2-73 as a novel treatment strategy for Rett Syndrome, Parkinson’s Disease, {{{and Multiple Sclerosis}}} will be discussed in more detail."
So... why on earth would AVXL want to start talking about possible MS testing for 2-73 if they know a PR from BIIB is eminent in which they will say they were not impressed with the results?!?
If this happened it would severely damage AVXL's credibility.
I infer from all this that the MTA has borne good results that have impressed BIIB. We should be seeing a continuation of the testing deal, and this should be PR'd when it happens.
If more than this is in the works with BIIB I'd not be surprised.
Again...all IMO.
No. You were off on the approval date for the second one. That's why I thought you were seeing something different from us. Sometimes it's hard to track all this info down. Glad to hear we're on the same page.
After you click the links you can find the application numbers for these patents. Then you can go to this website:
https://portal.uspto.gov/pair/PublicPair
Search for the application number.
The first one (application #13/940352) was applied for on 7/12/13 and is awaiting issuance. Should happen soon.
The second one (application #14/205637) was applied for on 3/12/14 and was issued on 11/10/15.
Looks like they were applied for in 2014.
The first one is the one we are all waiting to hear about soon. Should be hearing of it's issuance around beginning of September.
The second one you cited was issued on 11/10/15. Application # 14/205,637
Should be around sept 1st.
Based on what I've seen, we should see resolution of the patent and a PR discussing it before Sept 11th. Probably some time around Sept 1st or so.
Don't forget genetic profiling/testing which has been recently added to the analysis.
Actually, they have stated 3 trials starting this year and, as you say, have not backed down.
Rett phase 2 (possibly pivotal)
Parkinson's phase 2.
AD phase 2/3.
I think the theory that I have heard discussed here may be right. I think they may be waiting for new FDA regs. That would explain why the Sept 11th meeting abstract makes the statement about "we WILL BE STARTING a Rett trial" as if they don't anticipate having already started it by that date.
If we are going to start 3 TRAILS between mid-Sept and EOY... holy crap!! Going to skyrocket us. Should be sitting at least near $20 by EOY.
One announcement about any of the various HUGE catalysts will push this over $10. Daily price action shouldn't be any concern for a Long.
Noise, noise, noise.
Anyone from this board going to be at the luncheon at Rotary? Should be starting about NOW.
Hopefully someone will be able to give us some info about how it went.
Too much incontrovertible evidence piling up in favor of 2-73's future success.
Savvy Investors are not going to give away their shares based on misleading poppycock. Each hour that goes by we are that much closer to the reward.
Hang tight LONGS.