don't get it now, think of it like this. You are sitting with 4 pieces of a straight, all blue. Buddy boy raises you and you see him and raise him back. You pull the card you need and check. His name is ISE. But you know he's got nothing, so when he raises you to scare you out, sitting with a blue straight, now, you go all in.
His only way out is to scare you out.
CRO is the tell. They have to move and move fast.
WHO as you all know will be deciding on or about October 25-30th on the H1N1 vaccine. They'll be deciding on all the final issues. Deployment, ages, occs, the whole ball of wax. They also will be deciding on adjuvents,new treatments and whether to add H1N1 to the "regular" flu vaccines (they actually sort of decided not to for this year). Anyway, all this is dependent on the advisement they get from S.A.G.E.
Deadline is last week of October.
CRO was hired to dot all i's and cross all t's for the CDC, FDA etc. Cel Sci knows, it has to be done right, and quickly.
CRO is the tell.
Another take on the CRO .
testing on human blood takes 3-5 days for results(guess).It works they go straight to humans.But unlike most clinical trials the patients would not be volunteers ,they will be the public at large ,which takes a hell of a lot more work to document.Why else would they spend money on CRO.iDont think they would do this and waste money unless the results were already inn.Ive searched and still cant find another bio tech that announced the hiring of CRO.i know im grasping here but u can only analyse the info you have...
The CRO is a tell...big time. Do you think Geert would spend even a cent on a CRO knowing the demand on the cash for Multikine trials. He needs to rush something along folks....he doesn't want to delay or throw a wrench into what's happening with the manufacturing plant validation process by introducing a "need it now" trial within the plant.....so you outsource. You outsource for three major reasons:
1)_Third party validation of the testing results (good strategy, because now it's not just CVM saying we have something the CRO will confirm it themselves.
2) Cost: cheaper as CRO has equipment, validated process and resources available for:
3) Quick time to market...Geert has limited time to get this done. He needs resources yesterday, and CRO will provide additional hand and feet to get the job done.
Hiring the CRO was a great piece of news....it says A LOT about the confidence they have in their LEAPS claims. IMO>
Guys...I love the civilized and informative discussion in this thread. It is hard to come by on this board. Keep it up.
I've been in for a couple of months hoping that MK was going to go to Phase III in the near future as well as the facility opening up. I'm so exited at the moment and can't stop watching this stock.
Here's to washing out the weak investors and taking this to new heights!
I stil say the CRO is meaningful, however, I agree to disagree.
Onconasty is definity now "Not So Nasty". It's like in Dancing with Wolves, he has been re-named by his actions. There was a time.....:)
But, as the PR states, they have been hired to assist in the conduct of this testing etc. and.....
"In order for FDA to fully consider that next-stage clinical trial to evaluate LEAPS-H1N1 treatment of hospitalized patients with laboratory-confirmed H1N1 Pandemic Flu under an Exploratory IND, FDA has asked CEL-SCI to submit a detailed follow-up regulatory filing with extensive additional data. Thus, in parallel with ramping up its first study, CEL-SCI is proceeding on an expedited basis with the substantial undertaking necessary to complete this next submission. Recognizing that it cannot proceed with its next-stage clinical trial without the Agency's concurrence, CEL-SCI anticipates engaging in a detailed dialogue with FDA regarding the proposed LEAPS-H1N1 clinical-development program based upon this future filing".
Cel Sci needs their assistance if for no other reason than they have a lot on their plate, all good stuff.
ONCo .i disagree,Hiring CRO for LEAPS tells me time is of the essence,otherwise they would be conserving capital for multikline trials .remember it wasnt to long ago the hold up on multikline was capital.So why burn youre new found wealth on leaps trials .
WHO, will have a lot to say is efficasy is shown. WHO will (and potentially Gates Foundation) will need treatments for countries other than us. WHO is the major player and their decisions from SAGE will be based on reports of testing. CRO is the credibility factor we needed.
CRO was hired because this is a slam dunk.The biggest hold up will be the paper work. It takes three days to test leaps,dont u think it was a coincedence that CRO news was released about thre days after FDA CDC news.
Yup, but the last week of October is just the beginning. It all re-starts by then for sure, IMO. Could be much earlier. A lot of other things happening. In fact, Geert is probably busy delegating and hiring.
But on this front, CRO is the tell.