I found the overall tone of this report very positive in the manner it balances the FDA's regulatory responsibilities with the needs of the community for groundbreaking healthcare options and biotech companies need to innovate and bring new products to market.
cvac just seems to segue right into this regulatory environment imo and our patient selection criteria for the phase three trials probably encapsulates
"selecting the patients most likely to benefit
from a particular drug. These enrichment
strategies are expected to improve the
efficiency of clinical trials and serve as a
source of expedited drug development."
All very logical from the standpoint of using the people most likely to benefit from a therapy in clinical trials and if the therapy shows efficacy then the process towards regulatory approval is fast tracked.
One thing is certain, if FDA approval for cvac is granted we will be looking at a considerably higher share price than we are today!
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