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2018 expected to be big year for M&A, including Biotech. Reminds of old Grimms fairytales..." ole Braer fox, he jus lay there"..watchin
Most days we can only jus watch.
https://finance.yahoo.com/news/11-billion-biotech-binge-fuels-151013823.html
Makes one wonder what the flat earth guys will do when someone shows them a picture of the planet. BTW, why does the FDA keep using their limited resources on such things? Aren't there better things for them to be doing?
quote]Christopher Missling
Thank you, Clayton. I’d like to thank everyone for joining us today’s conference call to review our financial results and clinical progress. I am pleased to have the opportunity to share our exciting accomplishments from 2017, and give you a sense of some key milestones to look forward to in 2018.
Anavex Life Sciences is a clinical stage biotechnology company, focused on developing effective targeted therapies for the treatment of neurodevelopmental and neurodegenerative diseases under the precision medicine paradigm. This entails applying to a targeted treatment approach, genomics data and algorithm analysis.[/quote]
See post 136708 by investor2014 for entire link here...
Dr. M. has been saying this for over a year that I am aware of. IMO, we have recently begun to get a better understanding of where he was leading us. His position was well before anyone understood what was going on w/FDA new guidance. In fact we still do not understand where that is going to take us. IMO, like when J. Kennedy said "we were going to the moon" in ...some time period. He did not know when or how but it serves as a useful example of what a leadership statement looks like.
IM, this is one of those moments when it becomes obvious that the FDA processes forCNS indications are not working and we have no effective substitute, yet. Dr.M, G. and others stepped in it before they really understood what the consequences were.(IMO) Dr.M. is smart enough to take the point and to say nominally what direction AVXL is heading instead of blowing our $$$ wad away. I think he has a compass and knows the WAY POINTS (Ask T-38 what that means)...he wants to fly VFR but only IFR conditions exist on departure FBO and where we are going.
I can say from experience that developing AI tolls is an iterative learning process (not same as trial and error exactly but like it). The tools will begin to present functionality which will add value quickly after conceptual stages, but they are risky to use at first. He is saying, we have knowledge on CNS RETT and we have a tool populated with what we currently know...AND...we DO KNOW WHAT WE DO NOT KNOW.
I think he is saying we know enough about RETT indication and how to treat it and to set way points. We expect the destination to be VFR when we get there and we are certain we will do no harm. Now, this kind of leadership is typically valued in low usage, small companies. Will the FDA write rules around the Beta or wait/insist they lead when we all know they are not able to???
Just my spontaneous response...attackers hold fire.
No...read it again.
Read the post I was responding to. It is perfectly rational and correct to hold the FDA responsible to fix the regulatory processes they claim to have guidance authorship for. The amount of time it takes for them to effectively do that is what must be understood and responsibly managed by the FDA. When they do that and announce the plans then everyone will be on the same page.
[quoteThe lack of implementation of trials has been blamed on FDA as well as any other excuse this board can find. ][/quote]
Blame is not the word we should apply here, IMO. The FDA is a regulatory body, they own the PROCESS for new product approvals/development. That process for CNS treatment testing/approval is perceived to have been ineffective for a long time (see AD). Some process users are beginning to address that need while the FDA has declared "precision Medicine guidance...on the way".
This does not have to be complicated, but it will be. Commercial, competition based, free enterprise understand this dynamic very well. "Lead, follow or get out of the way", is the way one group puts it. We can deal w/it...BUT if youFDA stand up and STOP THE TRAIN then you BETTER know when and how to restart it. This is a PROCESS ISSUE, that's all it is.
[quoteThe lack of implementation of trials has been blamed on FDA as well as any other excuse this board can find. ][/quote]
Blame is not the word we should apply here, IMO. The FDA is a regulatory body, they own the PROCESS for new product approvals/development. That process for CNS treatment testing/approval is perceived to have been ineffective for a long time (see AD). Some process users are beginning to address that need while the FDA has declared "precision Medicine guidance...on the way".
This does not have to be complicated, but it will be. Commercial, competition based, free enterprise understand this dynamic very well. "Lead, follow or get out of the way", is the way one group puts it. We can deal w/it...BUT if youFDA stand up and STOP THE TRAIN then you BETTER know when and how to restart it. This is a PROCESS ISSUE, that's all it is.
PFE are doing a reconfigure of resources, that is all. New product development awakening has driven them to recognize a model similar to the one Dr. M. has described for new product/device development. If we listen and watch carefully we will notice the FDA is doing/has just done the same thing.
HUH...from this article link by Penny...see post 136665...small world. Reads a lot like what has been speculated here on what is going on w/trials. Also note recent posting by a team of Israeli scientists on use of AI tools. My own thinking is this what Dr.M has been up to and is linked w/new CNS FDA trial guidance.
Maybe the realize that future (Precision Medicine-CNS guidelines) will require all BP must reconfigure w/emphasis on computer analysis of indication. Having microbiology labs filled w/R&D staff will not be needed.
Steady T..good point
An unintended consequence of new FDA process position w/precision medicine.
Scott Gottlieb on CNBC if you missed it
https://www.msn.com/en-us/money/experts/fdas-gottlieb-our-goal-is-to-get-generic-drugs-approved-faster/vi-BBHRgt0
The end of the interview is interesting
posted earlier #136363 by Pineapple1
Mojo...
Nicely done, thx.
LGL...stop me if this sounds familiar to Dr. M's CNS words as well..also rings a little of the FDA Precision Med. work model and other speculation on why the trials delays. Yes, it is a connect the dots exercise but so what.
Thanks...saw no PR or other news ...may be dated though
granite...thx...I am looking to under stand the date of this pub??/Do you know??...I see 2017/what mo.?
test 8:23
If new FDA guidelines require more comprehensive analysis and planning prior to P2/P3 then micro Biotec investing should be lower risk than in past. In fact, an objective retrospective review of the past 20+ yrs of AD trials data w/new analysis algo's would (should) show what is now obvious. They never had a chance.
A lot of money and lives has been lost. We owe it to ourselves and patients lost to at least be honest and learn from the technical and procedural missteps by doing a decent failure analysis. I would like to think that the planned/hyped A2-73 new FDA trials are delayed b/c something wonderful happened(in the cloud) during the trials planning/analysis.
And for those who hype risks and enjoy playing dishonest mind games, pay no attention to this post.
Best to all longs, patients and their families for a great new year.
Talon...nice work. If the designated individuals demonstrate the leadership shown by members of this MB (TALON as example) we are golden. As you may know, recent (this year after 20+ w/o) changes to major international standards systems have recently EMPHASIZED LEADERSHIP as a critical/measureable criteria in systems accreditation. (NO LEADERSHIP, NO CERTIFICATE).
We will know it when we see it. The best systems/processes are just words w/o action.
Talon...nice picks, agree w/your overall sense of value. Would add an unknown around RWE. BOOM attributed to social media wildfires set by AD FDA CNS BTD due to Homeostasis CNS link validations.
Thanks Sokol...we are pretty much in the same place w/respect to the process capabilities of the FDA.
IMO...M has chosen to solve for science, not schedules. That takes guts and integrity. I am not happy either but I think he has made that choice correctly. That said, could he be more upfront about how he makes process decisions...??? YES.
For example..." I will always, in all cases, default to blah, blah , blah...". Then we would have to decide as shareholders ....will this guys EVER have ENOUGH DATA to decide?
anders....excellent comment/quote info...thx
SOKOL...please elaborate on this...