I agree with your statement here. Mainly because I see it difficult for the FDA to grant accelerated approval based on a trial with a small number of patients. I only looked at a few of the drugs granted accelerated approval, but each had trials of over 100 patients. There is always the possibility of the FDA operating outside of the norm, especially if the results are good and the data is clear. I hope for the latter, but expect we’ll need more patients for a larger trial for accelerated approval.
Regardless, positive results from the phase 1/2 TNBC trial will bring a nice increase in CYDYs market cap. The reduction of tumor size and reduction in CTCs are not placebo responses and will look great to potential investors.