Hi SS, I would have thought that a change from Phase 1 to Phase...

Hi SS, I would have thought that a change from Phase 1 to Phase II would require an announcement to the market.
Having said that we do have Fast Track designation and we are dealing with a cancer with a recognised unmet need and no real effective treatments available.
The Fast Track provides imugene with rolling data submissions rather than the usual slow and steady progress generally required for the above trial requirements.
https://en.m.wikipedia.org/wiki/Fast_track_(FDA)

Phase II patient enrolements are usually around the 50-400 in number and as well as safety there is some efficacy required, also RP2D is at this stage normally established due to the testing done with patients.

The Orphan Drug Designation provides further benefits in the way of 7 years of protection against competitors, tax credits, potential for grant applications and relief from certain administrative fees.

I dont believe it allows for a drug to skip from one Phase to another without the usual requirements including number of patients.
Although I would be more than happy to be corrected on this.

What is important and probably more so than the above designations from the FDA is that patients are living longer thanks to this treatment and no harm is resulting from this investigational new drug, like many others here I can't wait for the next results which could be better than what we all previously expected.

DYOR opinion only