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I agree w/your pr and read it as you say...thx...far from PUFF piece, the other BP would kill to have this capability and evidence of effectiveness
What kind of response would there be if BIIB, Phizer, others had this kind of results?
FLUFF...??HUH
I saw this PR as a peer reviewed validation by the "Who's Who" of the scientific community. I did expect some comments on evidence supporting BTD, but that's just me.
Will this be a kinda normal trade/business week as some have suggested or will it be flat due to holiday? Potential is big.
Tred...exactly. I see the 3rd parties as being big stake holders and an important part of the whole RWE initiatives. Believe the FDA(Gottlieb) has suggested as much. IMO.
Tred...I took this quote to mean the 3rd parties are helping w/RWE/trials/pts.The RETT parents, MJF, WSU and expert players are important to the CNS trials and related initiatives. These first trials are critical with many non FDA direct links. We need everyone in the tent. Going to be a shotgun start, IMO.
[quote]"I didn’t pick the 10 areas, the expert groups picked them." [/quote]
The most famous Samurai, Musashi has written,"The pen and the sword, in accord". Dr. M.has a plan. even he cannot control what others do/not do. But, I agree that sooner would be better.
Does WS history suggest any likely PR this week? Just curious as our pot is about to boil over, is this going to be a week off or not?
Someone suggested here a while back that nothing happens(historically) the week of Thanksgiving holiday. It is probably only 3 days anyways, just curious if anyone with WS knowledge has facts to prove/disprove the claim.
Time sure seems right to SAY SOMETHING and I would love to see a nice pop. But, the case could be made that this is such a technically complex and financially massive scenario involving lots of interests does anyone have the stones to pull the pin? I say YES, it's possible, the FDA will pull the pin on something and roll it down the table. They will open the CNS can.
Is there any historical precedent that comes to mind where big things have happened or is there tribal knowledge/ history that says nothing EVER happens Thanksgiving week?
INV2014...Agree w/
BB....agree with your thought on how linked events/pr's carry more visibility. We also have to keep in mind the FDA has already told us there are 5 CNS trials about to be announced. Also, the previous related stories from AVXL and links to 3rd parties with both influence and knowledge (Rett, MJF, AD w/MS/WSU potential). It is hard not to have high expectations. Maybe getting this all synched up is more than anyone should reasonably expect but all the components are there.
More than the hype, the presence of solid science and the urgent need for effective patient treatments make this a perfect storm.
Cool...thx
The short answer is, no. Any real, fact based discussion has been hard to come by. RGIN looks like it is real but could be a mirage. Remain hopeful for sake of pts and my interests.
Agree, my misread...thanks
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM585403.pdf
The new FDA guidance will certainly help w/RGIN product introduction processes and trials
Well, now what?
My guess is we soon find out what and how much homework/prep has been done while we waited for this FDA PR step 01. A very quick read suggests the 3rd party sponsors for Rett/AD/PD will be ready to engage. The FDA guidance suggests this 3rd party pre-work is key to kicking the accelerated process off. Considering the pre clinical/clinical trials work already available we should see IND PR to follow as an AVXL SAB/3rd party team effort has been ongoing. I expect joint FDA PR on risk-benefits-time line analysis and would not be surprised to see BTD.
These may seem like leaps but I believe most/much of the trials prep has been done and the usual timelines will not apply. We'll see.
AVXL will likely be named as a player/w others for the first CNS rollout, based on what we have pieced together. Five CNS new trials will be identified and five others. Not clear what typical FDA PR-conference looks like but It will be a big deal. Getting it lined up for timely delivery must follow some kind of official FDA rollout. NOT A PEEP? This is all real based on Gottlieb's and others comments.
How would FDA normally announce this? What kind of pre timed PR would be expected? Hrs, days, other?
Trying to get my head around the events which we expect to happen over the next few weeks/days. If the new FDA trial protocols are announced and if AVXL is part of at least 3 new trials(Rett,PD,AD..MS?AGX?)then a lot of med-tech news will flow. Analysts will be going nuts.
Is there any event/focal point/scheduled FDA forum where we see this happening? Politicians, BP, med industry will all have a stake in this. Any thoughts on how this will happen? Does FDA just announce and stand back or what?
Even believers need evidence....ASAP would be good.
[quote Gottleib's detour to Puerto Rico was unexpected][/quote].
You make an important point, IMO. If even 1/2 of what we think(A2-73) is in the works is true then we are looking at a political, medical, BP, science, regulatory, human condition/medical infrastructure chain reactions. BUT, this has to be all synched up. I hope I am wrong in thinking delay is political.
The facts are lined up (unless this is all just vapor) for events which politicians cannot just let happen. Our DC herd(read scum of the earth) will be on this like SOS.
imho...[quoteIt all goes back to insurance companies, special interests, lobbying and greed. The government is a conduit/middle man in all of this.][/quote]
A massive can of worms. What happens if a small clinical research company declares (w/proof) they have a "cure for cancer? or can treat CNS"?
T-38, this is a very important fact which we need to keep on the front burner during these worrying periods...THX.
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.