Good news regarding the FDA Very interesting.
Ask yourself why the "Breakthrough designation" milestone has been shortened to only 1 month between September 2021 and Feb. 7 2022 and that the "Commercialization" milestone has been advanced by 30 months (from mid-2025 to Jan. 2023) ... ;-)
The only possible explanation is; FDA.
It looks like the meeting with the FDA in August 2021 was very constructive.
When you look closely at the 2 corporate presentations (Sept. 2021 and Feb. 7 2022), they seem to have received positive input from the FDA that they could be granted "Breakthrough designation" much faster (and a shorter process) and entitled to receive $$$ way earlier than originally planned.
Take a closer look:
Theralase corporate presentation - September 2021
p. 13 shows:
- 24 patients treated as of Sept. 1st, 2021)
- "Breakthrough designation" milestone spreading between late 2021 to mid-2022
- "Commercialization" milestone starting @mid-2025
Theralase corporate presentation - February 2022
p. 11 shows:
- 30 Ph. 2b patients treated + 3 Ph. 1b patients = 33 patients treated
p. 12 shows:
- "Breakthrough designation" milestone being shortened (to about 1 month duration) and placed around November 2022
- "Commercialization" milestone advanced 30 months @January 1st, 2023, approx. 1 month after the end of the "Breakthrough designation" milestone.
Conclusion:
So it sounds like if :
- the FDA clearly understands the 5 key benefits (*1) of our technology and gave them new input at their August 2021 meeting and,
- that they've been told that Breakthrough designation would be a formality if data continues in the right direction and,
- that they would be allowed to obtain revenues because of that, whether via the Accelerated Approval program (allow to charge upcoming clinical trials patients (via the system) for the cost of the drug) or a via a jv with a big pharma partner.
*1: 5 key attributes impossible for the FDA and big pharmas to pass over:
- the impressive safety track record of TLD-1433 (QOL - Quality of Life),
- the high complete response (CR%)
- the high durable response (DR%)
- the low number of treatments
- the wider accessibility of the drug (non-discrimination among patients (i.e. not scanning for a specific genetic profiles, so making this drug available to a much larger pool of patients, when compared to Keytruda for example))