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ABOUT CEL-SCI AND THEIR DRUG MULTIKINE
Lots of good details can be found on their website: Cel-Sci.com. But the best recap is their Corporate Presentation.
-SEEKINGALPHA-
Probably the most accurate and concise articles written are:
- CEL-SCI: The Homestretch
- Setting The Record Straight on Cel-Sci
- On the Verge of Approval
- Learning From Bristol-Myers' Ipilimumab
Review all the Articles and Blogs from our 2 Authors:
-ZACKS-
Zacks is providing "paid coverage". Various reports here from them:
- October IDMC Report with Increase in Price Target: ZACKS IDMC
- Initiation: ZACKS.
TRIAL SHOULD HAVE ENDED IN 2017, WHY THE 'DELAY"?
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. The most recent Corporate Presentation 10/25 noted that the 298 event hasn't occurred.
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 Google Sheets 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.
STRAIGHT FROM THE CEO HIMSELF (BTW he has over 1M shares)
- On 6/18, this Conference video came out: Video
- On 5/16, a new interview came out: Video
- On 5/8, Geert issued a Press Release: Shareholder Letter
- Geert did an interview 5/2/19: ThinkEquity Interview
Phase II Trial Showed Complete Regression of Cancer!
During the Phase II trial, Multikine showed COMPLETE regression of cancer! Dr. Feinmesser’s report here:
SHORTS ARE SPREADING RUMORS!
CASH CASH AND MORE CASH!
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
FDA & IDMC Issues!
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!
Shorts Will Lie, Lie and Lie
Bashers Bash. See why here: https://messageboardfools.com/bashers.htm
They will say anything to make your give up your shares. Stay long!