In reply to@Hawkbar33
Lets see if you're really happy to be corrected ...
Paul Woodward was refreshingly straightforward. Hard to understand how he got through IMU's HR department. Anyway:
IF IMU can get the remaining 10-15 patients enrolled by year-end (2024), it then has to wait until the final patient in has had their cancer progress, or pass 6-months with no progression.
IF the results remain positive, IMU then applies for a meeting with the FDA to discuss the Phase 1b results and the potential for a Phase 2/3 trial. The FDA will take 70 days just to get back to IMU to schedule a meeting. There may be questions that come out of such a meeting.
IMU will need to address any questions and then submit a plan for the Phase 2/3 trial.
The FDA will take a period of time to further interrogate the Phase 2/3 trial plan that may involve some further back and forth with IMU.
If / when the plan is approved, IMU will be ready for FPI.
In spite of what Leslie says (in one of those paid interviews it was something like "we're running to the FDA like a lightning-rod through the land!!!!") I believe there is zero chance of all this happening by end-2025. The one-two quarter slippage is B/S in my opinion, and was basically confirmed by Paul Woodward.
Since IMU does an annual capital raise some (realistic) people would have seen the shareholder briefing interview and reasoned that two raises will likely be required prior to the commencement of a Phase 2/3 trial. Since IMU does each capital raise at a price lower than the prior one, its quite possible that two have to fit in between 5.4c and 0.1c. The size of the raise required to fund a registrational trial will make prior raises look like chump change.
High-11-figures SOI .... @slick will be having k'nipshes
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In reply to@Hawkbar33Lets see if you're really happy to be...
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