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TELESTA THERAPEUTICS INC T.TST

"Telesta Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the research, development, manufacturing and commercialization of human health products and technologies."


TSX:TST - Post by User

Comment by rgonlyfactsplson Aug 26, 2015 8:38pm
264 Views
Post# 24054559

RE:RE:NDA/BLA Review Process

RE:RE:NDA/BLA Review ProcessBeech...In addition to what you interpreted...and I quote for clarity..."So by end of day Friday or via news release Monday pre market we will know whether we get an RTF or priority review."...I also believe, for a BLA, the FDA will respond by Friday (60 days) if filed for "standard review" too. Note the "to all" in front of BLAs with respect to FDA issuing a "Filing Notification" letter (i.e., continues in the review process). The only info that will follow with the 74-Day letter relates to deficiencies, filing review issues. That's my interpretation but I have been known to be wrong (just ask my wife).
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