Media Thread, page-10476

First, thanks Gossy for the interview link.

Hi T-Bull,

I believe you are on the money when you say ...

That sounds very much like IMU is now narrowing down forthe 10 patient registrational trials that has been mentioned previously.
That might be why they had their strategy meeting.
Choosing the first cancer type to apply for breakthrough therapy.

If this is the case, it seems that they are seeing enough in ‘the signals’ to be able to construct an expanded trial targeting a very specific cancer.

I believe that the FDA will be much more comfortable ‘signing off’ on a Breakthrough Therapy designation if ... they can look at a specific cancer (eg. ILC or NSCLC). Once IMU has that, they can expand the range of 'targets'.

The Breakthrough Therapy designation is a process designed to speedup the development and review of drugs that are designed to treat a serious condition (like cancer).

Of course, any drug that receives Breakthrough Therapy designation is eligible for all Fast Track designation features. A BT designation would change the game for IMU and is, I believe, at the centre of Leslie’s comments and the need for this recent strategy meeting.

It seems very clear to me that LC, along with the team, are seeing strong ‘signals’ and these should soon be followed by full data readouts that will provide the required ‘responses’ everyone is waiting to see.

Hi Davy,

I agree with you also when you say ...

LC ... “with regard to turning cold tumours hot so that they are seen by the immune system - and that's exactly what our product does”.

That's about as big a hint as she can give that this is working.

Leslie must adhere to the FDA regulations and ‘recommendations’ when speaking about a trial that is still in progress ... it would be crazy to ‘rock the boat’ when you might be on the verge of changing the course of history. IMU’s scientists do not seem to have taken a mis-step yet, so why risk so much, when just a little more patience is required.

Hi Ben,
Your comments on communication are also 'on the mark'. As they say ... always know your audience.

As always, opinion only.