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Re: loanranger post# 233907

Monday, 07/09/2018 10:00:58 AM

Monday, July 09, 2018 10:00:58 AM

Post# of 403536
LR, I would not publish filing for BTD even if I were fairly certain of getting it. With FDA one never knows. Why take the risk. Most pharma companies seem to think this way.

As far as I know there is no FDA maintained lists for any kind of pending applications. Traditionally FDA does not publish details for applications (Oh, have I looked for them) only statistics. Approvals do get detailed publication, for now (my attempt for irony).

BTW: FDA is a great candidate for improved transparency. Most egregious example might be FDAs complete response letter , which FDA issues when rejecting an NDA application (Fool has a passable description without typical jargon). All publicity about it is left for the recipient. Even the existence of the letter ie. rejection of the drug application in its present form. You can guess how eager pharma Cos are to make that stuff public, especially small biopharma Cos.

"I would rather have questions that can't be answered than answers that can't be questioned." Richard P. Feynman

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