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Lot of moving parts here. Eventually, something has to give. We think A2-73 is not vapor and so do a lot of others. New patent news,the Sept.11 conference and FDA new trial rules all running a couple of atomic layers below the surface. Pressure is building for something to be whispered.
Bear..
Yeah, and what about the eclipse? Then what?
If this means what I think it means it is welcome news.
T-38, what an exceptional post you have done. Thanks. Can you imagine a room full of smart researchers who see for the first time a CNS disease treatment potential the rest of us can only wonder about.
bear..IMO you are going in the right direction here...
Very strong facts, well presented, Thx
Rey, agree w/your thinking. Complex but possible link. If they do sign the message it sends about A2-73 is massive.
Agree this should be read as good news for AVXL holders. We really have no idea what level of systems/clinical complexity AVXL staff are dealing with. We do know this ain't your father's Oldsmobile. Like you, I think IF Biogen does link up on an MS deal then that is a MASSIVE message on the AVXL science and overall credibility.
T-38, once again thx for your insights here. IMO, you are correct to bring up how the SAUSAGE gets made, it is critical that we have both political connections and the technical/clinical wisdom of the new protocol language on our team.
I have also considered the possibility that understanding CNS Homeostasis will allow FDA&AVXL to start to work to peel the onion of medical mysteries that have destroyed so many lives. As they do(IMO) and as learning happens a new dynamic will be added to the trials process. Hopefully Dr. Woodcock and crew will be out in front b/c this next few years are going to be explosive for the FDA.
TOGA.....TOGA......TOGA
At some point soon the cloud will open and new information will begin to flow. We should not expect cut/dry perfection...BUT, when the parents of the first little girl w/Rett see progress we will know this has all been worth it.
Wink, Wink. Nudge, Nudge.
The guy has been straight with us all along. Even on the worst days his story has been consistent. All the best to longs.
Falconer. Agree largely w/your message. News voids/vacuums cannot be respun/twisted/etc. Appreciate it if you would continue to scan the horizon for any credible CNS Homeostasis technical papers/other which contradict Dr. M.'s thesis, or any that reinforce the AVXL story.
powerwalker, thanks for your post.
The facts, dates, events which you refer to are a good sample of the behind the scenes work/information being boiled. There is obviously more we know about and probably a lot more we do not know about, all of which raises the bar on the importance of every little informed peep that escapes.
Those of us who are VERY close to every word are in wonder of the privacy/security being applied. We know we don't know a lot of things on trials, patent release PR date, Biib conference details, extended trial results, impact of new FDA trial regs and so on as you have identified so well.
NO LEAKS, not even an informed whisper, that's impressive considering what is at stake here. Makes one wonder about the things we do not know, we do not know b/c of the gaps above. I am inclined to believe that if this whole thing were vapor we would know or have leaks/clues/contradictions, considering the number of informed people here analyzing every peep/gesture/expression. This is reality, retailers and self declared experts are equally clueless.
https://www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/scienceboardtothefoodanddrugadministration/ucm556618.pdf
see sec3051 FDA estimate up 20% growth in BTD b/c of legislation.
Although many others will be candidates, we should have a good shot at rapid processing. It has been a puzzle to me how Dr. M. could be so certain of 3 trials in CY 2017 while he must have known the FDA holdup was expected due to new rules (September?). Hate to speculate wildly but maybe they are telling us the pieces to this puzzle are in place? After the crap we have been through lately it is good to have a positive thought at least.
Does anyone know or be willing to give and educated guess on what date the new FDA rules will take effect? TIA.
Well Done..thx
IMO, some trials PR is seriously needed but cannot happen until FDA discloses new guidance developments. We have been caught in a box along with others, IMO. Agree it is a serious/exhausting test. IMO, when new PR describes trials/rules then we may get insights into results till now. I'm guessing but believe the trial plans have to be put into some context (protocol/rationale) to make sense, then we will have facts. I could be wrong, it may be kept from public view.
Yep, looks to me like a little bush shaking going on.
Cullen, Is it possible we are seeing push/scare action prior to possible news from Dr. Mac F on Weds from Australia? Hope for pop in A.M. if not by EOD today.
Just a thought
Is RGIN static b/c we await new FDA guidelines for trials? New trial rules, technical, other will slow things up. Just a thought, held up like everyone else till sometime in Sept.
Is this why BP are either in denial or throwing up in their Cheerios right now? see Anavex pr April 3, 2017.
Is this any kind of indicator for when the FDA releases new trial guidance? Curious, a possibility. The sooner the better.
I understood him to say that a broader set of combined trial data could be used to validate the hypothesis of CNS homeostasis as the fundamental root cause of (3 for now) identified CNS diseases. This is simply my read of his message. If proven true then of course the term breakthrough is entirely appropriate and I will probably retire .
T., nailed it.
Jimmy, agreed...there is a risk of getting off in the weeds w/interpretation but it is low risk to say ...and they know EXACTLY what they are looking for. Yes, of course there is learning still going on but this ain't your father's Oldsmobile any more. Maybe not to late to save FDA which explains their motivation. It's a win-win.
blue. I completely agree with your message.
Timing of both events being same day could be a couple of random events just happened to line up. Hey, It could happen. Considering how cautious AVXL is with news, it seems less likely but not out of the question.
And, considering we read how the new FDA trials protocols will emphasize patients responses and quality of their lives in a flexible format, then another opportunity may have presented itself. Giving Mac F. a chance to take the point gives him and the Aussie's govt. a moment of deserved recognition for their leadership. But again, just coincidences.
And, the use of the term "Breakthrough" in the title for his talk could just be an unfortunate editorial oversight. It is likely NOT, a message to LOOK HERE by application of the most explosive term in the FDA trials dictionary.
Fun to speculate, unless you are short.
Thanks for link. I expect Mac F will not be open loop from Dr. M. and any key message. In fact maybe some kind of PR will guide him. That said, Mac F is not a big proponent of test data details in his previous talks. He spends time talking about how pts. feel/act/smile/reason. How has the quality of their life sustained or not? IMO, he will not free lance. It is curious though that the title of his talk includes "Breakthrough". All the best.
Little DD shows outline of talk. Sounds similar to previous talks by him. If lunch time in Melbourne then time in NYC?
Agree, sounds right...or the whole thing could be more high level dribble. If they wait so long to say ANYTHING you would think it would be PR'd.
Thx Mikesc...That just happens to be the day Mac F is doing his presentation in Australia ...when the "B" word is used in title..huh
Sent message to IR asking about PR on qrtly report...when, does timing synch up w/Dr McF's in Aus.? Will post if I get a reply.
Anyone care to speculate on the timing of this event and the U.S. AVXL qtrly. update? Note the use of a keyword in title posted. Maybe more to this?