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basparks...you seem to have a good sense of the AVXL event schedule and the likelihood of news.
Do you think there will be any technical news from next weeks conference? Seems like he has things to say and this would be a perfect time to do so.
TIA.
Thanks Mike...would like to see AVXL pull in any plans...unclear what this (PD,RS,AD) trifecta means in context of new Adaptive Trials rules. When results start to flow then special recognitions (BTD, etc.) may be in order.
Thanks Doc...my horizon is much closer than what is implied by this linking suggests. IMO, AVXL would have been a much better CNS partner.
Any thoughts on what BIIB is planning? Is this as good as it gets?
https://finance.yahoo.com/m/8253574e-55e7-3ea1-9381-9c6de5bf2933/ss_biogen-plunks-down-%241b-in.html
Consider this:
https://www.fda.gov/downloads/Drugs/Guidances/UCM070337.pdf
This FDA guidance doc on Risk Management for compliance w/21 CFR part 210-211 will (at some point) be relevant to all Anavex management, products and processes.
Enjoy.
Jimmy...GREAT MESSAGE:
CK
sokol...we are setting a new timeline using real time conversion of newly learned/understood concepts. That by itself is hard enough to do, and we are doing this with CNS diseases which have had no forgiveness nor effective treatment till now.
All of our personal clocks and inference engines must be reset to accommodate the new knowledge and using old cycles we are obligated to follow...or else. Time is something we each have limited amount of. Regulated processes have a way of delaying all cycles even those we normally blow through.
It is not clear to me how BP/big investors and the herd are going to react when they figure our what is going on here(technically/medically) with AVXL. A condition in physics known as thermal runaway comes to mind as an analogy. FWIW I am now sure AVXL has the goods, the science is real. It's the ,"SO WHAT" part I am not sure of.
SOKOL wrote:
Juvenile Toxicology: Relevance and Challenges for Toxicologists and Pathologists
Jonjones325...and Bourbon...
Exceptional, above and beyond. Well done, thanks.
Thanks tred...we are both more or less on the same page. we both still believe the science is valid and will pay off big. Time for me is getting shorter after a few years of this I am getting wearier and wearier. It is a marathon.
I was not ready for the big drop today based on no real bad or tech news.
I learned another lesson is the most positive way I can put it.
falconer...
I can usually find a pony somewhere but today's PR was not well thought out.
IMO, leadership must immediately put out a strong technical paper on RETT clinical prep/trials and exactly where they stand with the FDA. After being told that the FDA were being helpful/working closely w/AVXL today's RETT trial push was inconsistent with expectations.
As long as the science continues to go w/o contradiction we will recover and move on. They must have a strong-positive message from the ASM. IMO, thankfully the YMB is gone for good.
Xena...your assessment on this from todays PR ?
Top...no debate that today's PR left many questions. My response to ANY news could be easily misunderstood. We need to get clarification on the RETT trial ASAP/TODAY. The PR message today indicated to me they were tired of talking about it. Very confusing considering recent discussions.
basparks is BRILLIANT.....called it
Got it..thx
Anyone have details on shareholders session Tuesday? Time-Link for audio? TIA
Jimbo...commendations for a GREAT ATTITUDE
Thanks Doc for your assessment of these slides. We will need your continuing informed and rational thoughts over the next couple of months. Incomplete or poorly done work serves no one well. Please set the bar along with other qualified posters. The army of unqualified whiners and complainers will be ignored as usual.
By this time next week we will have seen/heard the AVXL..." what's next". The scope and level of detail provided will probably set the bar for the rest of the year at AVXL. We need M. to be detailed and global on RETT trial work (exactly-who/what/when/how/how much)?? Anything less just will not work, IMO. Ambiguity, Smoke and BS will be a big disappointment at this stage.
Based on other information, I am expecting much more detailed information on what has been learned about AUS AD markers. I expect a more restricted Precision protocol trial scope(who) will be treated based on AUS/other findings. We should also hear more about AD trial planning collaboration and any ongoing FDA role with RWE.
We expect M. to provide a strong report. The detail level and the scope of his talk will be picked apart of course, as he should expect that comes with the turf. He needs to present a scientifically powerful report and he needs to do that with thoughtfully intense leadership skill.
This is not about drama it is about recognizing patient lives along notwithstanding the current leadership vacuum at the FDA and BP WW on CNS. Lead, follow or get out of the way. As precision increases we should expect more focus on patients, what is happening with them and how can the learning process benefit those excluded from the currently treated pool. This whole process should be about getting real and not some abstract(SO WHAT) scientific exercise. Like we have said, if you want/expect to be in the room, ACT LIKE IT.
Nice catch. Looks like this got released 4/12, yesterday. During my discussion w/Anavex PR guy yesterday he was quite vocal about how supportive/helpful the FDA was being w/trials protocol-planning. IMO, if Precision Med. raises the bar for IND/PII requirements(as it should) then maybe we will see more of this kind of intervention. We are sure due.
tred...great message...thx
thanks...any link/price/other comments?
plex...BR...will provide more details later on today...no earth shattering stuff but to me....all very good to hear....NOW, I feel no gaps in trust and do expect Dr.M. will provide details as soon he is able.
trials will start also