IMU to meet with FDA next month., page-5

Hmm the FDA meeting is very significant, although it may take quite some time to complete.

My understanding from involvement in other Health care sector  companies is that the average time for processing a submission is 6-12 months.

However from the point of view of risk from larger would be investors it is a significant de risking milestone.

I would also observe that the anti PD-1 therapies are very widely used in a large number of very common malignancies, lung cancer is one which comes to mind at least, so from a scalability point of view it has much wider application than a Gastric Cancer therapy.

Also the issue of toxicity of anti PD-1 immunotherapies is a big issue, with many being associated with a large range of immune side effects.

So if it is that the Key Vaxx can deliver effective anti-PD-1 activity with lower side effects this will indeed be of great interest and utility across a broad range of malignancies.

It is also clear form the interview that IMU has sufficient funding to get all 3 vaccines through these initial trial phases.

Whilst the discussions about large pharma offers based on the phase 1b/2 data of the vaccine repertoire of IMU to date I have thought to be premature. An anti PD-1 Vaccine, Key Vaxx, I would regard as an entirely different proposition. Getting IMU to pass the FDA hurdle regarding dosing and safety of Key Vaxx would from a large investor/take over point of view be a much more logical entry point.

My thoughts, however I hold so take all that with good dose of skepticism.

DYOR!.

K