FDA is not OWNED by USA Big Pharma
While I believe there is probably plenty of the conflicts of interests and other shaky happenings, the FDA cannot mess with not approving drugs that meet their approval criteria and disapproving drugs that do not.
It would not only be ethically wrong, it could be criminally charged.
Just think about what the FDA was facing when QNTA showed up with their application:
SCORPION VENOM
There may have been laughter and who knows what else.
There was not much if any clinical trials or peer reviews.
Once QNTA started presenting the data from their at least since January and provided a wealth of data in March:
The Company assembled detailed information regarding the manufacturing of Escozine®, clarity on dosing, as well as both previous and new safety and efficacy data derived from an on-going human study taking place in the DR. The study has been conducted on over 500 participants and intends to demonstrate the safety and efficacy of Escozine®. Escozine® is a polarized solution of the Rhopalurus princeps scorpion peptide owned by Medolife, which has been filed with the FDA under the IND regulatory pathway as well as the Ministry of Health in the DR where the Company is seeking product registration. Previous clinical data was submitted to the FDA including preliminary results of the safety study, which has now been expanded upon. This data, as well as the batch of Escozine® that was produced specifically for the FDA, has now been submitted. After the review of the data and barring any further inquiries or requests, the FDA will designate IND status for Escozine®, essentially allowing the drug to be distributed in the US. After such designation, the Company will pursue other clinical applications of Escozine®, including as a potential cancer therapeutic where the Company has already released positive clinical results.
This current DNA Toxicology requirement QNTA is working on hopefully will clear the way for approval once it is completed.
While the FDA has open up the flood gates to get solutions for Covid 19 into the marketplace, they still have to do their due diligence before approving/disapproving drug candidates.
Escozine is an unusual to say the least drug candidate that probably has come through the FDA in its' entire history.
This may be one for the History Books.
