RE:RE:FDA taking a year for IBRX review Ben, i guess our definition of "receive" is differnt. in my world, "receive" means TLT gets or is granted BTD. I guess you difine receive as "apply". Not sure why you mention meeting with fda aug/sep 2022, they way i read it is that is when TLT applies for BTD, its so obvious, .lol...
ScienceFirst (7725)
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May 31, 2022 - 03:36 PM
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Post# 34721024
RE:When push comes to shove... Eoganacht ... Everything matches with the updated corporate presentation of Feb. 7 where they expect to
receive a Breakthrough designation around November/December.
ScienceFirst (7725)
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June 22, 2022 - 07:36 PM
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Post# 34775657
Ph. 1b patients #5 and #6 still cancer free after 2 years It's not the data of Ph. 2 that lead to the meeting with the FDA around
August/September 2022 but rather this 2y cancer free milestone. It's now obvious. The FDA must have been extremely impressed and gave guidance to Theralase regarding the next milestones. This lead to the modification of the corporate presentation on Feb. 7 where we saw commercial revenues (projected) advanced by 30 months. So it would be because of the Accelerated Approval program that allows for charging a price for the drug to the enrolled patients. Insurers, public health care systems then pay for the treatment. So Breakthrough designation (late 2022) and Accelerated Approval program seem a no brainer. Both program will have to give a response within 60 days of the application.