You put your finger on the big sleeper ...if Pt's are imrproving/recovering and not regressing the world will stand up and pay attention. Curious to know if any AD trial has ever gone this long, never mind being extended.
I have seen that happen in Jakata (now called something else) where a massive dump truck plowed full speed into a heard of pedestrians and kept going. When the cops got to stop the truck the driver was denying he hit anyone when the cops took him to the front of his truck and showed one pedestrian still stuck in the grill. True story.
I think you are exactly right. AVXL-A2-73 represents a serious conflict for BP investors and funds. How would an individual explain to his organization that he decided to cash in a bunch of Pheizer, Roche, etc and go with AVXL ???I can hear it now..."YOU WHAT????"...
The "in your face" cliff moment is quickly coming and (IMO) when the news breaks the avalanche will happen in an instant. An analogy, in semiconductor physics there is a state where all biases are set and no current flows until a certain predetermined voltage is reached, when the proper condition is reached then an avalanche breakdown occurs when current flow is complete-maxed out and continuous as long as the conditions are sustained. The biases in this case are the established BP conditions of ownership and a certain inertia (the last guy who did that got nuked). No Big Pharma has yet even come close to doing what AVXL has done, and they make mass quantities with the current portfolio of products. DO NOT shake the trees. (What could go wrong??). As someone said A2-73 and related science is about to rewrite the book and these axxholes are conflicted on what to do about it. ALL IMO of course.
IMO..we will see new methods for approval beyond clinical/lab/trials analysis. For example, if empirical (patient/medical/trials testimony-video-testing) evidence is allowed simply b/c no one knows what clinical tests are to be used as evidence of efficacy ...then ...it is what it is.It will need to be a retrospective validation...IMO.
The exact scope of any partnership is turning out to be a real problem here. How would one BP limit the use of A2-73 if it turns out to be an effective treatment for so many(unknown really) indications? We really get to a point where we do not know, what we do not know. I'm for careful limits on early deals. It would be a shame to give away the future perpetual motion device.
We are seeing an Avalanche condition....when will the sudden release of forces be shown?....what is trigger?
As has been pointed out by another poster..." allows us to formally move forward with the planned human"...is this code for off label use in AD Pt's??
Rett adds to list , although not an anecdote any longer, it was one not long ago...keep it rolling ...good things are happening here...every family and little patient thanks you
Jon, Totally agree w/your assessment on time and special conditions. This may just be a situation where the field experience of care providers and patients together with the prognosis for untreated AD patients carries weight along w/trial argues against convention. As for Rhetts, infant epilepsy, Parkinson's and the rest w/no safety risks the path to expedited trials seems open, for dosing at least.
aj...totally agree. People in a position to study and to truly medically understand what we are witnessing (Dado, others) are in a better position to comment of course. I have limited experience with a breakthrough in physics years ago and see that same pattern here. Simple, reversible, always true, fast, repeatable, consistent with a certain rationale, technically explainable as clear and almost obvious and with the strength of truth that even the most devious have to admit must be true based on facts. The dilemma is of course when is enough, enough? Just who is qualified to declare it and to call it as it is ...a breakthrough? This is also about major money and most importantly many, many patients whose families have prayed for such an event. IMO, that is what we are witnessing. It is early to say it but there it is.
Eventually, when there is enough heat, data, clinical facts, evidence of statistical confidence, what some call the tedium of credibility, then the rest of the world will know. But some of us sense it now.
If a retrospective analysis/review were done on multiple phony SEC "suits ..by ambulance chasers" on AVXL, what does this mean? Do they all get blown up or dismissed?