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That is a big part of the puzzle w/AVXL isn't it?
Wall Street-Stock market week?
Is this one of the (many) off (low volume/activity) weeks for the market? Seems quiet out there.
RGIN is due news -IND-BOOM..TICK, TICK
Bear...excellent work as usual...thanks for all the work and team play.
We'll see. I am hopeful for a good week.
Just in case..same link
https://parkinsonsnewstoday.com/2017/10/31/anavex-2-73-investigational-therapy-restored-nerve-cell-function-in-mice-with-parkinsons-disease-in-lab-study/
This is a good read ref PD and Lund. The use of the term restore is especially nice to see.
And yes, nothing good ever happens to AVXL....surprised you forgot to tell us about the coming ASTEROID....
bear...thx again for pulling some back from the edge....
Bio...love this..
No Really..MAXIM Grp rates AVXL buy...$14.00...we'll take 4 for now.
https://stocknewstimes.com/2017/12/11/maxim-group-analysts-give-anavex-life-sciences-avxl-a-14-00-price-target.html
My reading(bias) on what M. says has just shifted. He is a man whose projection statements will in the future be carefully filtered. Any time he says he is going to do something he must say a date and provide details for credibility. It is sad in a way but we have to evolve. As far as we know A2-73 will produce positive results, the sooner that is demonstrated by trial (Rett) the better.
He is a detail guy and should have no problem with this criteria.
JJ??
I think we are looking for clear leadership actions by the FDA(Gottlieb). Many of us recall statements on leadership like..."Lead, follow or get out of the way"...my own favorite is..."Leadership s like pornography, it is hard to describe, but you know it when you see it".
Dr.Gottlieb is not leading. He talks the talk but does not walk the walk. He must show/declare the CNS trials and then he must ensure they actually happen.
I am fed up with Washington and the incompetence of this critical regulatory agency.
HUH?
Very interesting thought. Everyone has a price. AVXL certainly looks like a massive apple ready to be picked.
We may never know how/why the wheels came off this 2017 plan. I guess I should be grateful I am not in some clinic somewhere (or a loved one) waiting for these guys (FDA/all others) to get their act straightened out.
When the FDA gets it's processes/conventions/rules and systems lined up and validated so that humans are not sitting in a room voting on the truth.
If M witnessed this FDA cluster knowing/thinking he had strong evidence of effective treatments but could not get them evaluated he must have been really pissed. Going for EU trials instead of standing in the endless queue was a guts call.
On Rett trial, do we know what if any guidance on the RWE will be relevant/in use? After all the FDA noise about new trial methods being applied along with other open practices?
from recent 10K...
"
Nicole...we get the whole.."It takes time" concept. Well thought out release on evidence of progress is fundamental to keeping the trust.
investor...I have no PMB...but, thx for clarification..
"So long as the FDA doesn’t come back with issues during however many days are left of the 30 days response time"
investor....so, there it is then....we go with, ANY DAY NOW...which we would all agree is better than(more specific than) just SOON.
whip...thx..
So then, on the SOON scale of time keeping according to FDA SPEAK when initial NDA discussion/agreement is done we have a process which defaults to ..."if you do not hear from us w/in 30 days"...then you can assume it is a GO.???Do I have that right? Hence..and so, (boys and girls) that is how we get ...Any day now.
Just a quick read?
seven...thanks for posting this. I get from a quick read a sense of growing confidence among researchers about their findings. My question is, at what point do the med/science community turn over the conf. room table and insist they run the game? We are staring at solid data and yet the BF/FDA process strangle hold on moving forward prevails. What do we have to do to get AVXL more visible?
Penny, any sense of when the FDA(other) will do the 5 CNS trial press release(s)?
Also consistent with the extreme caution shown in most all comm.
Unless we have been intentionally mislead, 2018 looks great to me as well. Bring it. I have no tolerance (hair trigger) for liars and so far M. has not crossed my line.
Sad to relate we live in a world filled w/liars and so getting ones axx shot off is easily done. I think between Rett IND/trials and news on MS we are going to launch..."any day now[/u]"...which is better than TBD on the SOON scale.
Agree. The new RWE feature will be worth watching. The trials process has been/is closed with respect to information releases (as it probably should be) this will change for certain, IMO. How interim information/leaks are managed will be important, particularly if one considers today's social media and the importance of pts status.
Although I would have preferred a smoother process recently IMO, we are OK and I expect a lot from AVXL science ....soon.