298! The Trial is OVER!
Delays are never good, right? Here is the thing... The trial ends when the 298th event (death) happens. But people aren't dying as fast as statistics would suggest for survival of Head and Neck cancer patients. Why? We believe its Multikine. Per the recent Shareholder Meeting on 4/17, we are still waiting on 298.
On 10/15/19, it was announced that the IDMC reviewed the UNBLINDED data for efficacy, safety and FUTILITY. Their recommendation: Continue the trail until the last event! Details HERE
Need more proof and you're a Stats Junkie? Then head on over to the Analysis created by our "National Treasure" FOSCO and team from the iHub message boards. These sheets estimate that we are now past 10% of Standard Care.
Probably the most accurate and concise articles written are:
Review all the Articles and Blogs from our 2 Authors:
Zacks is providing "paid coverage". Various reports here from them:
During the Phase II trial, Multikine showed COMPLETE regression of cancer! Dr. Feinmesser’s report here:
In October 2019, Cel-Sci released a PR stating that the IDMC has done their recent interim review and they made the following recommendation:
"continue the trial until the appropriate number of events have occurred."
More info on the IDMC on our IDMC page
This is a big fucking deal! At this point in the 9 year study, they have about 99% of all the data. They would know if the study was futile or not. If it was futile, they would have shut it down.
Recently, the IDMC has recommended to shut down 3 trials for FUTILITY. CVM just had the IDMC review their Phase III study for futility and recommended the trial should continue. The 3 PRs link below are from the 3 recent trials that were just shut down:
This is always an issue with Biotechs. Constant financing. Dilution. Wash, Rinse, Repeat.
We have plenty of cash to get us to the end of the trial thanks to a small but clean offering.
Visit Cash Page for current details
We all have heard the theories and assumptions about the IDMC and FDA hold. They are fodder for the Shorts! Here is what went down:
The IDMC was presented with data that indicates that the 1st CRO (Inventiv) screwed up the protocols and the 2nd CRO (Ergomed) is cleaning up a huge mess over multiple sites/countries.
They see some adverse events but are unable to confidently discriminate the causal factor due to poor data collection and protocol deviations by the PRIOR CRO.
The IDMC makes their recommendations and FDA gets involved.
Meanwhile, CEL-SCI is trying to manage the Inventiv screw up, so they recruit past the 880 in the original protocol and attempt to amend the protocol to increase recruitment further.
The FDA apparently didn’t like this protocol breach and the partial/full hold was made until CEL-SCI was able to show why the protocol deviations from the original approved IND were made. The FDA has apparently been convinced that the protocol goofs do not constitute a crippling flaw.
The study took 6 years to enroll instead of the planned 2 years. The original CRO (Inventiv) did not perform, was sued by CEL-SCI and CEL-SCI won the arbitration. The CRO was found to be guilty of material breach of contract.
From the PR:
“This is a final and binding decision and to CEL-SCI’s knowledge, marks the first ever decision in favor of a biomedical company against a CRO for breach of contract"
Inventiv messed up...bottom line!
Bashers Bash. See why here: https://messageboardfools.com/bashers.htm
They will say anything to make your give up your shares. Stay long!
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