they didn't skip the pre-clinical or pilot clinicals . the preclinical was for dosage and efficacy and had 8 volunteers . the pilot trial had 32 volunteers .
Yes, as a stand alone product/treatment is does not have to have trials to submit to the FDA. But, if it is used with existing or potential drug treatments to reduce side effects I believe they will need trials to be submitted at some point...?
Just like the current trials being done on hydroxychloroquine + zinc + azithromycin for treatment of Covid-19 by various agencies. The efficacy of each one by themselves have been proven but their combination needs studies/trials...?