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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.
You are correct...no link shown...post 133946...looked right
plex...credit find to investor2014...but thx and I am looking to see progress against that target effective immediately...unless something is presented which proves the science is incomplete/seriously flawed....IMO the sp will be north 0f $200
SWEEEEEET...
Anders...your timelines and events are plausible.
I am also puzzled however about the whole FDA new protocols and the process changes we heard so much of recently. Now what? Will RWE practices be considered and will they impact evidence trail/PR/News? The old trial (view the world through the FDA straw) go away or will we still be captive to the same processes that got us nowhere for past 10 yrs+?
So, I agree w/your scenario and % estimates but think the context of trials will be very much changed.
Bear...you wrote and I agree...
W/BIIB ...I think you guys are correct. Very strange w/WSU strong data on A2-73...looked like a deal was in the works then...silence...not our 1st rodeo though...pressure needed from somewhere...Rett results could open some eyes...as far as we know A2-73 is an effective treatment where everything else has failed...hang in
JJ ...If he knows the A2-73 results will be positive and if he see FDA dragging their feet (who knows why) he concluded ...AT LEAST I can get something started if I go w Plan B. We will probably never know. All we can say was he was in a box of his own design...things to never do again.
Along these lines, I think Dr. M. went with plan B. Between FDA confusion new protocols, BP resistance and long list of TBD...The guy just went with what he knew, so what it is not FDA direct , maybe he saw that as a ++.
Thanks for insights. I see, the 2 for and 3 for have not been emphasized. Maybe Dr. M will be even more cautious.
Sure. The PR reports no Q4 trials starting, although it does talk to IND for Rett. You predicted correctly that we would see uptik. Just curious as to how you read the events and PR?...nothing complicated
In the meantime; what other BIOTEC AD/other CNS developers are awaiting trials approval? Surely AVXL is not the only firm in this queue? Any CNS trials to new FDA rules been announced in passed weeks?
The fishing analogy works if you add a few things.
Around here (coastal) you will study the tides. You will study the bait fish. You will study the time of day and weather. You better know where the shoals/rocks are. Study the wind, read related reports. Study the time of year and the schoolies. Get out when it is right. Watch the surface for bait fish breaking. Watch the sea birds chase surfaced bait fish. Get the right gear ready. Be ready(if blue fish for example note they can easily take your fingers off). Find the fish schools, fish the schools and stay there until you cannot raise your arms to cast. Done.
That is also how you invest if you are smart. On the other hand you can just throw your line in and hope. Very few longs here have just stumbled onto the right context conditions. I think we expect (on some scale of confidence) that positive CNS results will happen w/A2-73.
Dr. M seems like a serious guy not given to blowing off a lot of smoke. Many qualified posters here have discussed and assessed the science. Trials so far are consistent AND there is no evidence of contradiction. Is it a perfect scenario? None exists. Most good fishermen do their home work and judge the conditions. Just beware of liars.
JJ, we all hope you are right about next week.
Worst case they can scale back some of what is said/planned. What amazes me is the very low leakage of any possible plan specifics. We will se before open on Monday(IMO) how good the leak rate works.
trader..excellent observations, gutsy points to make
Changes to FDA trials protocols are certainly a factor here. Required resources to deal w/FDA must be a factor in any planning. Recent sign of trading life are positive, IMO. Note, all BIO are going through the same thing w/FDA new rules.
[quoteAnavex climbs the 'Wall of Worry!' Accumulation of big lots today][/quote]
Well put characterization of our current situation. Nice summary-status of our situation but could you assess the future likely trials process media output? With the new RWE and caregiver sources of results Do you expect a more dynamic-interactive reporting process than historical norm? I am thinking we will not see the world through an FDA straw as is typical with prior trials.
Just curious, are you aware of any other new trials by ANY other bio/pharma that would use the new trial protocols in the same time period?
Bear, extraordinary, fact based and informative post. well done.
Mike...know what you are getting at. The dynamics are massive and complex, not easy to get political, medical, financial, etc. And, involves many human stories w/understandable emotions. Scheduling/planning anything of this complexity is beyond difficult. Eventually some leadership will evolve if this is going to make this happen. Icebergs are tough.
Thx...sounds right
Xena,
How long do we get played like this at low volume? Is this about some trigger event that bounces volume and sp? or are there other factors? Some shoe will drop and we never look back...my wish.
PW...thanks for the great link.
WAY