As previously mentioned, usually FDA is not the problem. They probably communicated right around mid-may that BTD is not positive and expect the letter to come in due course! As usual, the company did not communicate this conversation and waited for hard copy to let the news out! "Report back" is lot different from communication!!! Clever use of legal language to rebuttal to SA article!!! I also seriously suspect that SA already knew the bad news and in my deepest consipiracy theory, the news was obtained from PVCT itself to allow all their friends to sell the stock before official news today! Basically, they let the bad news out via a blog and waited until today when all their frinds sold the stock!
FDA previously communicated concerns regarding the development program and provided advice regarding the type of data that should be systematically collected to investigate the clinical benefit(s) of an intratumoral treatment of a subset of individual lesions in a systemic disease (malignant melanoma),
Hate to say this, guys, but Regulatoryexport called this again, even the date, saying they'd probably received it mid-May. And, jesus, the PR the other day saying they hadn't been informed. Now that I don't understand.