True that
Listen, I am not very smart. What I have learned through the journey with Cel Sci for just over a year is miniscule. Don't have medical background.
From my understanding, there are so many types trial designs. If you had the opportunity to listen to the presentation this morning, you heard Geert allude to the FDA and how over the recent years, say within the last 10 years, it has changed it's approach to drug approval.
When Cel Sci was designing it's trial, it had to get FDA approval before starting the Phase 3.
There was no interim peak at the data, designed into the trial. If there were an interim peak built in, what would it tell? The benefit that Multikine is designed to achieve isn't realized within the first two years of drug administration.
HNSCC is a killer over the first couple of years once surgery is complete due more to the devastating effect on the Oral cavity. Tongue cut out, jaw bone removed, teeth removed. Such disfigurement, inability to chew, eat, etc. Devastating, so much that people die from those complications.
The effect that Multikine seeks to prove is that it can eliminate the micrometastasis that spread from the tumor into the other parts of the body. The surgery, chemo, radiation regimen take it's toll on the immune system. The weakened immune system have no capacity to fight the micrometastasis that are present in 20-30% of patients. These are the ones that find themselves in a life or death fight with cancer's return.
Anyways, an interim look wouldn't have shown that benefit. Multikine needs time.
Believe the premise in all clinical trials authorized by the FDA is that the Sponsor is removed from the medical process. Greatly lessens the possibility of bias from influencing the process and the outcome.
Therefore the Open or Blinded doesn't refer to the Sponsor, but the actual trial participants.
Those who received the Multikine injections, knew it. Those who were enrolled were certainly informed about the trial and it's medicine and that they had a 4 in 7 chance of receiving the trials' drug. That is what is referred to as an Open trial.
Hope this helps.
