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Xena
AVXL from down under rally is likely based on past performance. On the other hand, the best team that money can buy, NYY has been all but statistically eliminated. Maybe the NYG will do well....yeah right.
SOKOL says:
OK, we'll see I guess. Lots of guidance written on this kind of obvious issue by FDA.
Bourbon:
f1ash...all very good points. Yes, we will need to hit a lottery or make moves to achieve the goals. I am hoping he can sequence actions/results to minimize the impact.
powerwalker, thanks. Yes, it reads better. The structural sequences and (shall/may) delivery is till inconsistent w/today's needs and technological capability/style. Overall, if sponsors must wait they are going to be looking elsewhere. IMO, if AVXL gets results by going a different path the FDA will have to adapt instead of insisting that everyone else follow them. IMO.
Kentucky123. Your observation makes good sense. It s possible to get too close. I am planning to buy more here.
ihidfromtheX...honor to meet you. I think you are right, others may take time to see. http://defense-arts-center.com/articles/2016/2/22/karate-ni-sente-nashi
Another one (CNS Disease pfizer) bites the dust.
https://finance.yahoo.com/m/4100621f-94f6-3abe-ba1a-b4f4b494c9e5/ss_pfizer-stops-developing.html
Any thoughts, clues, explanations on why AVXL sp continues to waffle-edge downward or what ever the technical term is for what we have seen since last trial start PR? I am open to rational conspiracy theories as explanation. SP seems to have no correlation with potential of product plans or healthcare system need. A2-73 is at least as viable AD option as BIIB's.
BTW, if it is due to some shadow competitor effect please provide evidence.
Thanks Kevli33: Dr.G. says ...I have broken the code below.
dia76ca
Extreme said..
Is it OK-rational to HATE a color? Red is a really lousy color.
Powerwalker, thanks for the link and information. I remain baffled by the BIIB AD product development efforts. The management seems to have a blind spot around the Amyloid thesis long history of failures. Yes, they have a lot of money to throw around so their campaign seemingly stretches over the horizon. I get the sense there is some kind of silent showdown w/AVXL being played out. Anyone who holds BIIB stock should be paying attention.
Is this reported BIIB "progress" from their PR 8/28/18 positive news or not positive news?
Steady T:
Are we (AVXL) the only game in town? We here are typically cautious about even thinking this way much less saying it out loud. And of course we have our resident gloomers and risk predictors. So, we try to keep some rational low key context, it is what it is.
Curiously, A couple of weeks ago the BIIB boys were openly folding their cards. Example:https://forextv.com/market-news/theres-new-evidence-that-the-dominant-approach-to-alzheimers-may-be-completely-wrong/
If I were a big cash holder of stocks and wanted to make a pile more, and if I thought I could move the AVXL sp a little then I would. Once down as far as I could get it, I would jump in w/both feet. Then I would let the smoke clear a little, blow my BIIB holdings up and create something positively dramatic (TBD) about A2-73.
But, I'm not yet wealthy and would not own BIIB anyways. So now I am going to go buy a few more lottery tickets.
Riddle me this...?? Why is SP down after the first Precision Medicine trials for the largest WW CNS disease is announced? How can such a move down have any correlation to this PR?
https://finance.yahoo.com/news/first-patient-enrolled-anavex-life-110000178.html
BTW...BIIB down in pre market today following (AVXL&BIIB) PR's. Does this suggest that their latest Amyloid thesis try-all will go off as a gas?
Talon...here is new design link...look familiar?
https://www.newsweek.com/irans-new-fighter-jet-copy-us-plane-1960s-military-experts-say-1085804
T-38, thanks. I keep getting hung up on the difference between guiding and leading. I'll get over it. Curious if the latest Iranian AC design looked familiar to you. They just announced it a couple of days ago. BR
Thank you for information on IND process. I am familiar with it. Also, thanks for confirming that the FDA's method for establishing priorities is based on whoever walks in the door next.
Curious. Does anyone know the basis for "who's Next" in the decision/processing queue at FDA? Is it public welfare? Is it total systemic cost? Is it politically based on who is in office at the time? Is it the number of patients/cost per patient/overall healthcare system costs?
Is there any score sheet anywhere that tells us when a priority will be set for AD trials for example? (not only AVXL) Maybe when we get an idea then the details being speculated here can be considered in some sensible context. Who is in charge?
I do see an opportunity for big impacts being managed in a rational and positive manner. No one here really has a clue on why these decisions by FDA are taken? We assume there must be some one in charge w/a plan. If that is true then we sure should be asking why FDA spent the last 20+ years using process methods that produced nothing of value for treatment of AD, and BTW where is the FDA plan for all other CNS priorities or do they just wait for someone to walk in the door w/an idea?
Sure would be nice to have a rational-fact based-status discussion, including any facts on process changes and relevant impacts. Just like these were serious issues.
Kentucky 123 says..
More on connecting FDA dots.
https://www.fda.gov/medicaldevices/digitalhealth/
Some of us here have reviewed how the FDA MUST KNOW they have process issues. Of course all of that is to be expected during periods of significant technological evolution. We might argue such concerns are particularly notable in CNS disease-land where complexity/criticality and innovation are always up next...bottom of the 9th, w/bases loaded and two outs...seems to be the ongoing game plan scenario.
If one does a little checking(google searching) around. Guess what, you're right. The FDA is in a process kerfluffle and it is impacting what gets done and when and who does it and when will they get funded and all the systemic rest. Not to mention the political and BP human exponents in every CNS decision.
So the GOOD NEWS is, we are right, the BAD news is we are right. The use of other systems (countries) to conduct arguably the most important testing of the century (CNS Multiple indications) may not be pretty but it is an important and correct choice (IMO). With the belief that there will likely be multiple treatment refinements going forward we have little choice. If we wait around for the FDA to fix itself we will all be dead. Good move M., execute the plan.