Replies to post #40373 on Cel Sci Corporation (CVM)

[H2R]

Hi Tarius729,

In case you were looking for a reference around that point:

42:35 – One question here is. Ok, after surgery, it is determined that whether you to radiotherapy or radio-chemotherapy. Well how do you give Multikine, how do you determine that in advance?

42:45 – And obviously, that was the first thing our team thought of, and our team has determined a way, a clear way to ascertain which patients would end up receiving only radiotherapy following surgery. So we have that and so therefore you can easily prescribe for that patient indication.

https://www.cvmresearch.com/p/cel-sci-investor-call-to-discuss

Is that the one you were thinking of?

Best of luck with your investments!

[Biobonic]

Kenny Nolan had a big hit song titled 'I Like Dreamin' back in 1977

Another poster has cut and paste the transcript that details what you thought you had dreamed.

Yes, it's true the staff at Cel Sci have crafted a procedure for determining who can receive Multikine prior to surgery.

Questions:

Is this a modification of SOC?

If so, what kind of approval would this modification need from the FDA?

What would the approval consist of? A clinical trial?

Does the staff have the medical expertise to tell members of the American Head and Neck Society how to change their approach?


Submit the BLA, all their trial results and when do they tell the FDA, oh by the way this will work if it's determined prior to surgery whether or not the patient will need chemotherapy.

FDA - from our understanding, the need for chemo versus just radiotherapy has been determined after the surgery. That is when the medical professionals can determine the extent of the invasion of the cancer. But your drug needs to be administered prior to surgery, and how do you determine, prior to surgery that chemo will or will not be a part of the SOC?

Do you have any trial results to back up this 'new' procedure that varies the SOC?


Just saying, it's not a slam dunk.

Is the FDA just supposed to approve an unproven change to SOC?