There have been tons of threads regarding P3 trials ranging from when the final batch of MK should be finished to how long we'll have to wait to start getting results from the trial.
I haven't seen too much discussion about the time required to actually enroll the 800+ patients around the world, which Geert stated won't begin until the sites have taken delivery of the Multikine.
The IRB approvals are rolling in at a good pace, and all we can do is speculate about the timeliness of the MK production, but what is the consensus for how long we'll have to wait for full enrollment once the MK has been shipped?
At this pace we could have all the approvals in by the end of the month, and I think its reasonable to believe that MK production could be finished by that time too. So is it going to take 2 months to fully enroll the patients? Are we cutting it close to get the trial started in 2010?
This thread is messed up.
Some of the people are talking about IRB approvals, and others are talking about pt. enrollment. AND NO ONE IS READING WHAT THE OTHERS ARE SAYING, or if they are, they're sure mixing their metaphors.
Good luck sortin' this out,
it's not an enroll first study, it's treat as they come. The full enrollment really means the last of the 800 enrolled, and by then the first 799 will have been treated or will be undergoing treatment. Meanwhile the 'race' is on, the results will be available long before the study has finished the last of the 800.
Thanks for clearing that up. That makes me much more confident that the P3 trial will begin before year end.
So does that also mean that the trial can begin site by site? In other words, if Multikine production were complete tomorrow (or yesterday!) could Cel-Sci presumably ship MK to the sites which have already received IRB approval, and those sites could then start enrolling patients?
I think Geert discussed it some in the last shareholder's letter, but I can't remember if he said enrollment won't begin until ALL sites have MK on hand, or if he said enrollment will start at each site as soon as MK is delivered. The difference would be an anouncement that is a month or two off to an announcement that could be days or weeks away.
Whatever the case I think its going to be exciting around here for the next 3 months and I'm expecting some of those sweet 10+ million share days ahead.
just spoke with my BGF at Covance, she is a clinical trials APM....as far as enrollment and trial are concerned its first come first served...there is no waiting to be seated.....recall there are over 45+ sites and there is no point in waiting around.
I agree that it will be a pleasant surprise if the trial does actually kick off before year end, but its not out of the question at this point.
The original estimate was Q3 commencement and that was pushed back to "by year end", so I think it would do wonders for Geert/CVM's credibility to avoid another delay (even if that delay were just another month or two.)
One or two months for such an important milestone is no big deal, but the idea of Geert actually following through on a timeline would be a big step forward in terms of his credibility/reliability.
I honestly don't have a clue how long it may take to enroll nearly 900 patients for 49 sites all around the world. I would imagine it should be a couple months at a minimum. I also wonder if and when we'll be informed who the CRO is. Maybe once all the IRB approvals are in we'll get a little update or shareholder's letter with info regarding the CRO and patient enrollment estimates.