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my observation has been that when people arrive at a similar/same point from different directions then that is usually a good thing. The opposite of contradiction. (from
[quoteI believe Dr. Missling and Dr. Gottlieb are aligned to start the three trials this year with the 21rst Century Cures Act with possible funding.][/quote]
Good to see this bit repeated. Months back a short PR from Gottliebs office indicated they we ready then w/approvals but it was taken down w/in hrs and not seen again till recently.
It is refreshing to think that the "science and statistical rationaliztion" of sanctioned trials process direction which allowed the whole "plaque" thesis to prosper for decade in spite of repeated failures is being called out. Here we (US-BP) are decades later broke and clueless still. One can only imagine how Gottlieb/Missling must feel to conduct CNS trials based on RWE. Finally.
Thanks Bear,we'll see.
Anyone have an idea of what we should expect from the MJF-PD conference on 10/30 ? Seems tightly managed and low key.
Sounds good to me, Roll em'
Anyone know if Dr. M plans on heading over to Paris to be in the room when WSU speaks?
Nice POP at end of trading today. Hope and pray it is a sign of things to be sustained, soon would be nice. Very much appreciate the recent insights posted here also.
[quoteHas always been the plan for the quickest approval and path to market. ][/quote]
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Agree and also believe he chose Rett as a trial which could show very early and dramatic result/influence. I also think he anticipates a validation of his CNS restore/regen thesis which SHOULD result in a snowballing effect on subsequent AVXL trials (PD-AD-MS-other) as pts/families anticipate effective treatment. If that does happen then obviously SP will move quickly.
right, just looking to see if/what might be out there. any news and boom, imo
Nicole...waited long time for good news. I own many shares for a long time. Bought b/c I liked what they published ref FDA support/IND work/plans/goals looked to be well done/rational and positive. But, no action for long time.
Can you say what and when will be published/proven to get us going. For example, progress w/FDA or plans for trials or $$ positive support. No splits, no share dilution, just solid results/progress. TIA
T-38, appreciate your complete and helpful response. Sounds like a wait and see but w/some + possibilities. I agree based on my own read. Thx
T-38. Why would BIIB hold or be silent on MTA results? Is it as simple as money?
Bear Nails it. It has happened before...try ignoring AVXL if all else fails
Seriously, what is your prognosis for how the rest of the day/week will go (SP?). When we get popular here soon(+/-) what do you expect next?
Thanks, I do remember seeing this excellent work you did. I guess we will just hide and watch from here.
Dr. Peter Senge.
Mike...yes, BIIB could be using WSU for backup data, that makes sense. The timing of their decision vs WSU release is what puzzles me. MS research being reviewed by experts who are discussing your bread and butter product field while using A2-73 as the model. It is established that BIIB was said to be evaluating the same thing is at least curious, IMO. Did BIIB actually evaluate A2-73? (assume Y/N) And then what happened? Are their findings consistent w/WSU? I hope that bubble gets filled b/f the conference.
A Good day..agree w/you on keeping reasons private as appropriate.
The whole MS-MTA-BIIB combination of events and current status does not make sense from a science/business standpoint. If BIIB did evaluate (MTA) A2-73 and if A2-73 performed as WSU and others have said then why has BIIB passed? There may be a perfectly understandable explanation but so far we just have to scratch our heads. It looks like on 10/27 WSU etal will review more of their research results re MS-A2-73. I expect someone to say something between now and then. In fact that speculation may be why we are seeing a little volume and price interest today.
I think another reference(analogy) using the discovery of penicillin might be useful to help. There was no accepted AAHHAAA penicillin moment b/c it's use on a wide variety of infections/bacteria was not part of the thinking at the time. Had medical science said at the time, "hey, lets try (fill in the blank) on N different kinds of infections and see what we get", then the whole process would have gone a faster path. But, no claims made and the dots did not get connected until years later.
That is not what is happening with A2-73(IMO). Dr. M. has claimed that A2-73 restores CNS cellular functions which should/will restore same across multiple (unstated) indications. If these 3 trials are used as evidence of validation for the process of CNS cellular restoration/regeneration in a generic sense then we get an AAAHHHHAAA moment.
Meant to say an (AAAHHHHHAA)sp moment.
Is a three-for-1 doable? Fantasy? In a way yes to both but consider this.
AVXL has plans to review data from WSU/PD/PK\PD/RETT/AD all in a period of a few weeks starting soon. If at some point over that time there is an ...(AAHAA moment). If Dr. M. claims these to be proof of Homeostasis restorative/regenerative efficacy by A2-73 across CNS spectrum (fantasy yes ...BUT). Not hitting a bullet w/a bullet but delaying/stopping/reversing the CNS failure process. Validation of the thesis is not as tough as claiming a final solution, it is the beginning of a new CNS learning process. We probably all expect this solution to be expanded and applied to many other indications with varying degrees of efficacy. That is what I expect anyways.
All the work he has done is (IMO) related to properly setting expectations, if that is done adequately then the rest if doable, IMO.
Got it, but silence sticks out like a sore thumb.
Box of chocolates argument...you just never know.
I would say that the events are already planned and if the results are as evidence to date suggests then stand back...she's gonna explode....will Dr.M. add more fuel? If I was him I would.
Well guys...if we are right about the dots as defined by several here(whiskey/bear/others in the form of a list) some connection sequence and pattern should start to appear. Ride low in the saddle and stay off the horizon. Best to all longs and patients.
Anyone have an idea on status of IND or other RGIN important points of progress...this is getting old fast...
So, with BIIB in the room (so to speak) and with WSU doing a read out on A2-73 results and with the world knowing BIIB had MTA w/A2-73, how do they remain silent? At a minimum wouldn't they be obligated to say something like...,"we're working on it."?
BTW, that was my best Polarbear immitation
[quotewhen tests show that A2-73 proves remylination in vitro whilst
DM failed..pretty strong stuff..very exciting..][/quote]
OK, any thoughts on how long such testing would/should take to complete.
Grtherd...thanks for reply. Any thoughts on status of RGIN IND process/project w/FDA?
This pr was written over a year ago. Is it normal/typical when tests are done to have zero pr follow up? Not suggesting anything just do not know what is usually done, no pass/fail notes? Is it, if silence then...???
Attila...Excellent connect the dots posting. The really good news in all this is we have no shortage of dots as just pointed out again in an exception Polarbear post.