Massive on the huge scale...w/Pfizer likely lead...added value w/A2-73/Viagra combo...standby for product naming contest....
My theory is these 2 were chosen b/c they have demonstrable talent/skills which were lost and have been recovered, therefor easily demonstrated, dramatic improvements...I have to be believe if they had any math majors or famous speakers/authors they would discuss them. For most of us it would be hard to demonstrate before/after with any scale of importance. ( I used t forget my name but now I do not...)
Agree, considering the risk/benefits relation here and already declared ( I safety) results. The worst that can happen is they do not recover, same as no action at all. The logic (other then cost) of the current thinking does not fit together. I do not believe another massive, long trial is the only/best path. In the meantime the FDA ponders and people lose. How about some leadership, not just remain as cops.
Vols, agree with your point, it seems obvious. What I do not get is why BP & players are so negative? yes, of course it is $$ and control but if the science is there they all lose big time. This next trials result PR will stop the universe or at least shake many orbits if consistent with first look. DR M. silence is at some point unsustainable. I would look for clearer heads to prevail here and we will be rid of the AF/motley fools forever. That is my fantasy I guess.
Nothing soft about this..."What I learned was, they're basically meaningless. James A. Hendrix, Ph.D."...we must react.
Time for you to do your magic. I am good with either, BTD, ODD for A2-73, Trials partnership, MJF grant, closure on selected patents, other FDA guidance or any option of your choice. It's your call. Sooner the better, no pressure.
OK...well, they definitely did have very brief ...few words and then shut up...sounded like they were aware of some FDA WIP...very nervous, cautious exchange...strange...but it did happen.
About 9:15 this Am JC and Carl were going back and forth ref FDA impatience...he then said they are waiting for this AD breakthrough...Carl repeated that a few seconds later...like they were referring to some event...did not get any more, no names mentioned...anyone else see ...hear?
Been thinking they show the painter and the Piano player because the evidence of recovery is dramatic and profoundly impressive. My guess is there are other stories as well but less impressive b/c someone remembering where they left their keys is not as newsworthy, even if it is evidence of recovery. So, this could be less anecdotal than first impression. Many have possibly recovered but their stories are simple human life with nothing showing artistic skills or capability. Those cases may refer more to testing, IMO. It's all good.
mich...agree. He makes the point as we all would for example about a common head cold cold. You may break the fever but still be unable to breath, taste, live normally. When the cold has passed we make the judgement of recovery based on how we feel. Fever-temperature can-will recover with time but I would rather feel better with a minor residual fever, which is after all a lagging indicator in this example. The only real question here is will every patient go through more or less the same kind of cycle/experience and how relevant are leading/lagging indicators?
If Dr. M and team already have (leading/lagging) indicator data, and most say they must, then AVXL staff may have a truly miraculous story to tell. There may be some who do not fully recover. Strong patient stories and corresponding analysis of recovered cognitive skills should be next. Cannot happen soon enough for me.
IMO, new methods of showing a compelling case for expeditious trials and release will be developed. Such as this simple video suggest. Even the FDA can/will be influenced by compassionate case applications. This ain't your father's Oldsmobile. This is just too important and too dramatic, assuming results continue to show.
rw....I have been thinking the same way. Looks like he is building a context within which discrete additional news will/can be developed. Brilliant plan if true.
Agree, truly impressive. Is this consistent with early data suggesting stopped cognitive regression, which we have been holding our breath on? And, not only stops on-set but then symptom reversal potential. It looks like there is at least a couple of examples. Almost too much to hope for.