RE:RE:RE:RE:Oh not again...Yep, what you do is run a statistically signifcant Phase II (IND-213) and then speak to the FDA in a post-Phase II meeting, and then you request Fast Track designation..
Special Protocol Assessment (SPA)... How do you get a SPA ?
Well, a company REQUESTS a SPA from the FDA when they want to meet with the FDA to reach agreement on the design and size of certain clinical trials, clinical studies or animal studies. The purpose of this process is to determine if these studies adequately address scientific and regulatory requirements for a study that could support marketing approval..
The FDA granted ONCY a SPA to run a Phase III in mBC. So this means ONCY must have presented FDA with a trial design... then when the Phase III as Matt had claimed in "fireside chats" failed to materialise (my contention becsue they couldn't find a partner) suddenly we're told, "oh, the FDA said we should look at blah blah blah".
BS. The FDA had approved their Phase III, and the truth is, they couldn't find anyone to pay for it... Come on Azzak, are you really so dim you cannot see this...?? Matt and co have kept Pela under a cloak of fuzziness since that time... one unpowered statistical trial after another...
Unless they get Pela approved by 2028, then the patent will expire, and even you can then brew up some Pela in your backyard, combine it with a sprinking of pixie dust, and get a marketing authorisation.
THIS is why we have no institutional interest... because no-one believes the data, and one patient in panc being cured, can be a fluke... how do we know that it wasn't something they ingested that actually worked... or placebo effect. We need MORE data.
I keep making rational posts to counter your fantasy story, and the very best you can do to challenge my point of view is to spew peurile insults. dear dear.
I fear you can't work it out, as only a simpleton would write..
"When you test drugs to cure or improve illnesses l, like cancer for example, it takes a real long time."
you don't improve illness Azzak... you improve a patient's symptoms and/or condition... jeez. It takes a real long time... how long..? Well, if ONCY had started it's phase III five year ago, by now they would be submitting their BLA, anfd they could have used the money generated from sales to pay for more trial with a variety of CPIs. Matt even said this on a recent call... so why waste 5 years ? and what happened to Roche 'pulling the trigger' after Aware-1... and why did Aware-1 take 3 years when Matt is on record saying it would be completed in a few momths..???? No-one believes ONCY anymore. You only have to watch MC's body language to see how out of his depth he is... Please please BOD, fire this Homer Simpson lookalike.
it's you who will end up the loser, unless you take profits the moment you have some... nuts