ATLnsider, and Gary I actually agree with what you both have stated in principle regarding all four RAs' buy in for the adapted endpoints as per company's previous communications and the fact the data was locked on 5 October.
But if that is a certainty. It would have been useful and meaningful for the company to release a PR saying so. So it feels there seems to be something ongoing between the company and FDA. My intuition is it must have been something more than making ascertain of buying in for adapted endpoints, like Gary suggested. It always strike me that the first second endpoint is regarding recurrent GBM. I wonder if this endpoint is met, should the company request FDA to approval DCVax-L to treat recurrent GBM as well, at least conditionally.
All in all I believe the company should issue a PR regarding adapted endpoints and RAs acceptance if all are onboard, if such PR would not poke the eye of any of the four RAs.
And I also believe there may be something more on the stake and the more we wait the better the outcome will be.
At this stage I think the primary and at least some secondary endpoints will be met in a statistically significant way, and UK and German's approvals will be in the bag in due time. As far as the FDA is concerned, I believe it will be ultimately onboard and approve DCVAx-L for nGBM, and even more for rGBM as well as long as data is good enough.
The fast-changing, seemingly genuine mood swings in this board really point to too many small potatoes who are holding sharees probably from a few thousands to less than a few hundreds of thousand shares at one time, and constantly trade in and out of the market. For me these are just white noises.
For some others who are genuinely on the mood swing syndrome maybe they just can't see the forest for the trees.
News 
Market Data 
Discover 
AI
