TELESTA THERAPEUTICS INC T.TST

From Telesta's NR

[1wascallywabbit]

0. The FDA has a 60-day filing review period to determine whether Telesta’s BLA submission for MCNA is complete and acceptable for filing, whether MCNA will be designated for priority review or standard review and whether an advisory committee meeting will be scheduled. Their decisions on these items will be communicated to Telesta in the FDA’s official filing communication known as the “Day-74 letter”. Telesta will communicate the FDA’s filing decisions upon receipt. 

[1wascallywabbit]

Basically telling us we are not to be told til day 74, even if Management knows sooner

[princeofcut]

rabbithole, a card carrying TST bagholder posted this idiocy ''Basically telling us we are not to be told til day 74, even if Management knows sooner""  stunning retardedness...either rejection or acceptance of the submission is very material news..period any non-idiot (or someone posting fraudulently) knows this...IMO this is what will happen, FDA will notify TST exec

[cheetio]

....Applicant must be notified of a refusal-to-file decision (via RTF letter) within 60 days after the original receipt date of the application