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tradeher...[quoteso the FDA would have to explain to The Donald why everyone else had the most needed drug in the World and the USA did not. ][/quote]
I thought the same thing. Then, within a matter of weeks, BP dropped their respective AD-Amyloid hypothesis trials like hot potatoes. And, we noted, they never got any press/ink/news..NADA. Except for BIB they all got the memo and walked, IMO b/C they knew it was a loser and that the FDA was backing off. No one ever said a peep, no seeking A-B-C, no apologies for putting you through this hell, etc. Just POOF , gone. They all walked and now BIIB is still in denial. We'll see what happens next. They just brilliantly ripped off the market to an awful lot of $$$. Whoever pulled that one off should be asked what's next?
If A2-73 scores well next week the people who bailed out on Plaque trials will all be hero's but they will not be able to talk about it.
Hi Talon...thx again for your read of the BIIB latest.
As I see this in a showdown kind of AAIC line up, tactically BIIB just blinked. A little bit of change the subject, smoke, deflection and frankly axx covering. The most recent BIG PR when they talked about great news trail stuff they ended up w/a massive amount of money buying in. How would you feel if you bought that story and shares then this pile of stuff shows up?
Yes, they have lots of $$ and a big PR budget as we can see but they are thin on science. IMO, they know they are thin on science and are doing the old spinning plates, trained seals, dancing bears multi ring approach. The media needs to print/copy something so they will follow BIIB instead of the German guy w/the funny hair. Works every time.
I am staying w/the science guy but dancing bears are always neat to see.
Kevli33...yes.
A famous guy(Dr. Peter Senge) has commented something like this...there are 3 levels of knowledge..
1. Things we know.
2. Things we know we do not know.
3. Things we do not know, we do not know.
Best served w/a slice of humble pie.
from above link.
https://finance.yahoo.com/news/data-presented-biogens-alzheimers-disease-113101527.html
New PR from BIIB
Anyone care to comment on this (kitchen sink) PR. Note the placement of latest BANXXX.
This might be seen as a type of cover effort b/c of credibility loss lately as shown by even SA.
Interesting strategic move but ...REALLY?
walker, Good question, I just want him to be clear and decisive to the extent the science allows. I do expect him to comment on the nature of the precision medicine learning process and each iterative scientific development. After all, we do expect he will be showing AD+ results that have never been shared or proven, any one of which is worthy of note by the room. Hope he shares not only what happened but why it happened.
The BP in the room will be anxious to see what he has. We have all been through a lot even just on this board over the past 3 years+, I can imagine what M's staff feels. After this they will all hit the famous wall of exhaustion. I think we need deals to be done and announced (soon) so that moving on is the responsible and proper thing to do. IMO, if he really does present what we hope then the rest of the world may just step forward and insist large scale action be taken. Even massively good news could get tricky. He is smart enough to expect just about any possible outcome.
Above all he must connect the dots in a convincing way so that we are all able to move on.
Biostockclub...Brilliant work. I said then and repeat, the executive management at BIIB that allowed that last PR is about money,only. Stuffing the dead Amyloid hypothesis down someone's throat would be appropriate at this point and we are likely to see it happen.
There is a big baseball rivalry in the NE U.S.. Fans of these two teams not only want to see their team win but they also want to see the other guys lose. That is the kind of victory we want.
IMO, if it were not for the precision medicine initiative, we would never witness what we are about to see. We are saying that the amyloid hypothesis will be disproven. Most of the BP has already resigned themselves to that. But, either their signature(MF) will be on the paper or...
it's complicated, but you get the idea.
XENA
The SP response was noted here at length by some of us. We saw immediately that the PR had low technical merit and that the SP bounce was not based on sustainable results. Nothing has happened to change any of that. Points to the scale of challenges faced by AVXL. There's an old expression that does come to mind on the original BIIB PR, "You can't shine SHAT".
biostockclub...Thanks for once again adding significant value here.
https://seekingalpha.com/article/4187666
The article linked by you and here points out how vulnerable stockholders/buyers are/were. Some of use here had an immediate GAG reflex when we read the original PR piece seeing that the hype was not technically justified then or now.
All the best. BTW, I am w/David on this match.
FROM PR 070318
http://www.neurotropebioscience.com/
Noted similarities homepage design for NTRP and AVXL. Looks like a good potential BIIB score also? Just saying, RETT, Fragile X?. Some of this stuff you can cut w/a knife, IMO.
Stay alert out there.
Read on, they are not exactly the same although I understand your point.
https://seekingalpha.com/instablog/6460311-unemon1/4985776-behind-neurotrope-clear-overwhelming-links-fraudsters
Would BIIB and NTRP have an understanding?
OK...thx...need/want to see some positive outcome here ASAP.
Tred...agree w/you comment-observation.
Dr.M. has been very directly sticking his finger in the eye of the back room guys. IMO, he understands full well what he is up against. AVXL have taken the time to get their story cleaned up for AAIC. We simply do not yet know the level of detail/complexity that he is ready to present.
IMO the presentation should include 2 main stories. One story is the science-technology linkages which (hopefully) relate to responders markers/definite trace information which is then reinforced w/visual (PET) and powerful statistical knock out blows. Pull no punches. Second story should include RWE/RWD, patients/videos/witnesses, possibly live interviews. Not snake oil stuff. Something that brings "Precision Medicine" to life.
At all costs avoid back room/black magic/stay tuned messages. This is the Precision Medicine Renaissance Moment. All the dots that matter are connected. The level of documented science presented must be consistent with the level of risk and the criticality of the moment.
baltimorebullet wrote-
Jimmy...
Kkevin says…
Kevin...your suggestion is by far the best one we have ….NO ADVERSE SIDE EFFECTS ...EXCELLENT, must also include highest sleep quality. Agreed.
Cannot be taken lightly.
BR
Nice...and you get some green group credit good for a breath of fresh air.
falconer...like the way you think. BTW, no one knows what the answer is but at least we are beginning to think about the question. Thanks again.
Thanks Huntsman. Any thoughts/insight on when we will movement here? Need to see signs of life soon.
We'll see won't we. I predict we might learn that the internal politics and AAIC deference to BIIB are a big factor in positioning. The massive $$$ from BIIB PR when it timed in was a big eye opener as I would have previously thought such things do not happen. The most generous description I can give to the BIIB PR as written is sloppy. There is no way the FDA can seriously consider their results w/o adequate system validations. BIIB states in their own PR that they have not completed and analysis of results. Why was that dropped before they were done? No response required, we do not know.
IMO, these events happen in the sequence they do for a reason and not at random. We'll see. I also continue hope for the best here but am also watching b/c there is more at work than the science IMO.
jimbo
Questions I ask as we approach AAIC.
1. Would Dr.M. pull in an AD trial and announce it before Rett trials if he did not have an AAIC slam dunk? (no-IMO).
2. Is it likely he will show a direct link w/Biomarker analysis to responders? (Yes-IMO)
3. Will Dr.M. do a presentation at AAIC that shows a clear link to markers w/PET results that support patient related responses? (Yes-IMO)
4. Is it likely he will present evidence (RWD,RWE) of previously confirmed AD patient recovery, like video, AD Chorus, other. (yes-IMO)
5. Is it likely the AVXL team will present further evidence from Academic and Healthcare sources which further validate efficacy claims? RWD, RWE. (Yes-IMO)
6. Is it likely the FDA-NIH will respond favorably to new AVXL CNS disease initiatives? RTT, other (Yes-IMO)
7. Do you expect strong WS/BP/Fake Media support-praise and appreciation for the AVXL AD results, which they have endeavored to achieve for decades and have failed miserably to do? (No-IMO)
8. If BIIB claims are not validated by FDA should they be directed to stand down until they do so? (yes-IMO)
9. Is this a David v. Goliath Grudge Match PR showdown between AVXL and BIIB? (yes-IMO)
Xena, sorry, I do not know. Am not able to check today but will look when possible. BR
https://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm572939.pdf
just an example of many such docs from FDA on how to convert anecdotes into RWD-RWE which may then be submitted as evidence in drug files. We should be looking forward to many such examples in the future. I think the concept is great however it obviously wants to be carefully managed.