Looking at AIPAC 03 trial design:-P2 run-in up to 12 patients...

Looking at AIPAC 03 trial design:-
P2 run-in up to 12 patients trialling 90mg dose and Paclitaxel. Depending on outcome move to

P2b - up to 52 patients using 30/90mg dose and Paclitaxel. Administered at same time and all above is open to TMBC (78% of all breast cancer).

Kick-off this quarter. P2/P2b funded from existing budget. $??m.

P3 - would assume 300-500 patients? Not budgeted and therefore would need additional capital or partner or new owner! Cost P3 - many variables but base cost $50m to $100m plus. Important to note overall survival is mentioned as P3 trial endpoint as opposed to PFS in AIPAC 02 which narrowly missed this endpoint target.

Now OS as a target will take much longer to complete.
There will be interim data of course but it may take 3-4 years to complete.

So, imo unless there is a BP saddling its white horse to fund AIPAC 03 a significant cap raise will be necessary early 2024 or sooner.

Some may recall BMS was the originator and owner of Paclitaxel before it came off-patent and now 'generic' chemo. Just saying....

PS - anyone from clinical background advise why in the original trial efti was not dose escalated (as in AIPAC03) to find maximum biological dose? It seems to me like it's been after the horse has bolted. Just hope this time the horse has BP Knight on it!...,

Happy Easter holiday everyone. Time for a few cold whets and relaxing long weekend. Cheers H.