CEL-SCI Corporation (NYSEMKT:CVM) has today announced that it submitted its FDA response. This was in reaction to the recent move by FDA to put hold on CEL-SCI Corporation’s Phase 3 head and neck cancer study with Multikine* (Leukocyte Interleukin, Inj.).
FDA in its letter outlined that the “Dear Investigator” letter as well as the study’s Investigator Brochure (IB) required some revisions.
Numerous deficiencies and their locations in each of the documents were indicated, after which specific directives were assigned as to the specific information that necessarily needed to be included in the revisions.
According to some people close to the company, CEL-SCI Corporation followed the provided directions and made the appropriate revisions. The company’s luck hangs on the balance at this moment.
Incase FDA gets fully satisfied with the revisions; the company will proceed with its activities as usual. CEL-SCI Corporation has its fingers crossed in the hope that FDA lifts the clinical hold. The company’s insiders show that about nine hundred and twenty-eight (928) head and neck cancer patients had successfully enrolled and even completed treatment in the Phase 3 study which inspires hope.
CEL-SCI Corporation has also said that currently there are no other studies in progress. It is waiting to get the response by FDA before proceeding to make the next move. The lifting of the current hold by FDA will boost the company’s confidence and through channeling resources to the right projects it will be able to rise again to become an industry leader.
The provider observes the move by FDA as one targeting looking out for the well being of patients around the globe. It was necessary and it promises to do much better after making it through the current challenge.
The head and neck cancer according to research is a condition that has been claiming a lot of lives in the last one decade. CEL-SCI Corporation couldn’t take it seeing so many lives lost and that is why it chose to channel resources into research to help find a top solution to the complication. It believes that it is close to finding the solution and using it to help millions globally.
