Vorlorn- you are reading way too much into what the pr said. No where does it say "FDA said turn in the paperwork on BTD....60 days after we give you your certificate....we may make you do a short bridging study...something simple and CHEAP. "
It is not guaranteed the FDA will give them their "certificate" as you say or that the bridging study will be "simple and CHEAP."
It is nice to be positive but what you wrote in my opinion is plain misleading. Anyone who has been around Biotech knows the FDA is filled with surprises. Nothing is guaranteed or for certain.
Unfortunately too, PVCT's earlier pr are some what misleading in their promising "clarity." Unfortunately, as some one on another PVCT board wrote, "clarity from the publication of the type C meeting minutes, and we still don't have clarity. Clarity would have been the FDA granting BTD with abbreviated bridge study guidelines for a small patient population with short endpoints (tumor reduction or ablation). What we got was the filing of a BTD request, with an uncertain future as to acceptance or rejection of same."
I am still long PVCT but disappointed by management's handling the pr with the FDA.
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