Hi All,
Well IMU have surprised us yet again! Thanks to all for your thoughts & to @jip123 for sharing your email with LC. That gave us a clue.
Clearly something has changed in a big way since LC assured investors we had enough cash to fund trials this year & we had enough coming in from conversion of oppies (including the BOD).
My guess is it’s for a multi-arm Ph3 for Her-Vaxx & potentially including existing on market checkpoint inhibitors or other (@davybabyk it’s interesting Ph2b was renamed Herizon when there was another checkpoint inhibitor trial running in the USA of the same name??), & that they will go for accelerated approval on interim results (during the trial) on a couple of hundred patients (I think the last one that received this was on ~290 patients on a Ph3), similar to some recent checkpoint inhibitor trials, where OS was still pending.
This may also be possible because something I didn’t know until recently, is that gastric cancer in the USA is considered to be Orphan Status (this was from an article I posted on Media Thread some time ago in regards to treatment of gastric ca in the USA).
Accelerated approval can be granted on Orphan drugs from the FDA as well as a single Ph3 trial.
It appears some cornerstone investors are will to stump up a load of cash at a small discount, which is also very encouraging.
Anyway, the plot thickens & just my thoughts, I could be wrong. The manufacturing comment gave a clue, because we have enough to fund currently, so likely for a much larger trial.
GLTAH
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