No FDA sanctioned trials have ever been conducted.
it passed so many tests...
Oh wow. Maybe we should skip CTs on that basis.
the drug involved has already been approved by FDA
Not for use in 2nd line PC. In fact in other past CTs, the use of Ifosfamide for 2nd line PC has failed.
and cell in box causes no immune response...
The goal is not to stick a bead into a person, and the immune system not to respond to it. The goal is to treat the cancer. It has never been shown CIABs are required.
I am still thinking that FDA needs more time to understand how this works and to study the tests and previous clinical results..
The FDA employees are not the equivalent of High School kids requiring months to understand a simplistic antiquated treatment from 20 yrs ago.
30 days seems not enough time and so we have this hold..
So the bottom line is FDA scientists on the review committee need to visit the PMCB site, and watch videos. Along with reading over 200 Kenny PR pumps, in order to understand it as well as SHs?