Another big scoop at the end of the day! Most are green with yesterdays being the exception with a dramatic drop. Doesnt matter either way with me as I am waiting for bad news only to part with my shares and if history continues to repeat itself, like it has so many times now with no bad news, well then I guess we will have to just wait and see how good the news actually is. Is data so good that approval is accelerated for one or more indications within the next 6-12 months or will we still be hanging the carrot out one trial at a time for the fda?
I am still of the opinion that we are still trying to “back in” to an umbrella or basket trial. Why one may ask?Perhaps the continued AI digging has given us the confidence and supporting evidence to make the case for the next 4 phase 3’s that are mysteriously waiting to start in the wings, may be why! Or, very strong safety (DSMB) and efficacy to date, may be why! Also very strong trial designs with predetermined outcomes of efficacy for endpoints that may of been met and or exceeded, may very likely be why! How about that RWD and RWD followed up within the OLE’s supporting placebo patients recovering after taking the drug…. could this very well be another great reason why! The greatest presentation would be if the two ex FDA veterans put IT all on the line and with, all of the above combined, made for the case to start one giant, whatever you want to call it, trial where as Anavex, through their possibly much perfected trial protocol and AI assessments, can “plug n play” short 7-14 week trials for a myriad of Rare (or not so rare) diseases where the case continues to be made pre clinically and with predetermined outcomes being met…..or exceeded (think “less dementia”)!
I think we are way past this stop and go, paper mountain duplicating, red tape of a process by now. After hearing about Anavex’s plans to start a preventative Alzheimer’s trial I think Dr. Missling and team are in the position of presenting something rather unique to the FDA, hence the delays, but not for conventional trial reasons, imo. Our CEO doesnt seem to be the stand around and hold your drink kind of guy after 6 years of a “rolling trial” system!
All the above is just a laymen’s observations and opinions. No magic beans were formulated or produced and no wages were placed or lost in the time I spent formatting these ideas. Everyone do your own research and place your bets appropriately based on your own risks and not on others opinions.
As Tone Loc would say ”….less do it!”
Cheers
