A fast track straight to pivotal trial-wrong
will certainly happen
Again, the FDA never grants fast track to any drug/treatment without data from a clinical trial first. And your order is backwards.
Also note a "pivotal trial" or study pertains to medical devices, and their safety. In PMCB's case that would cover CIAB beads. However, that term is meaningless, when applied to ifosfamide to be given in Metronomic chemo doses. Once again, the FDA would need to see the data first before granting the results for CIAB to be designated as pivotal. It would then require follow on data to determine the effect of CIAB+Ifosfamide.
Where's the IND? No IND, no clinical trial of any sort. As the months roll on, there will be plenty of time for Kenny to dump more stock.
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