It's not the data of Ph. 2 that lead to the meeting with the FDA around August/September 2021 but rather this 2y cancer-free milestone for Ph. 1b patients #5 and #6. It's now obvious with the timing of this milestone and the meeting with the FDA.
« … with patients five and six demonstrating CR with no presence, recurrence or progression of the disease at up to 24 months post treatment." 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 (see the 3 links below). 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.
Accelerated Approval program = Possibility to charge the drug for revenues:
August 2021:
Accelerated Approval—An Unexpected Pathway To Value-Based Pricing? May 22, 2022:
Study: Blockbuster, accelerated approval drugs more likely to get new FDA-approved formulation May 24, 2022:
Medicare Spending on Drugs With Accelerated Approval