RE:$TLTFF NMIBC NONRESPONSE FIRST IN CLASS. The Corprate presentation is of no interst to the FDA
The Company newletter is of no interst to the FDA.
The FDA is interested in the data to date.
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May 19, 2020Shawn Shirazi went on to say, "In a 3Q2019 conference call with the FDA, it was discussed and agreed between the FDA and the Company, that Theralase would potentially be eligible for Fast Track Approval
("FTA") post receipt of the FDA IND authorization, based on the clinical study data collected to date. It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation ("BTD") and / or Accelerated Approval ("AA"), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated."
Its all about the DATA TO DATE not the copr prz or newletter.
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The FDA wants to talk about Data to date...
Nov 23, 2020As a Fast Track designee, Theralase® will have access to early and frequent communications with the FDA to discuss Theralase’s development plans and ensure timely collection of the appropriate clinical data to support the approval process.
floatinketucky wrote: $TLTFF SESN ran from .37 to six buck on the NMIBC NONRESPONSE FIRST IN CLASS. They are on the backburner... not up to par.
TLTFF current levels to over six buck an hour soon.
The Gold Standard for NMIBC Nonresponse.