Media Thread, page-8971

Hi Dicky @DickyB

As you would understand, in the area of drug development, no two cases are the same, so there can be some variation in the way the FDA requests a sponsor (eg IMU) to proceed.

For the most part, the FDA recommends that sponsors consult with ‘the Administration’ on the appropriateness of co-development before initiation of a clinical development of a combination. There are all sorts of good reasons for doing this, one being safety of course.
So, in my opinion, some level of consultation would likely need to happen, with each ‘combo’. Of course, if IMU provides a long list of CAR-Ts, that they would like to ‘combo-up’ with, then perhaps it may take a different form. We will see.

Sponsors (like IMU) would normally be asked to provide evidence to support the biological rationale for the combination, in both … ‘in vivo’ or ‘in vitro’ models, that are relevant to the cancer that the drug is intended to treat.

Short answer … lets wait and see. If onCARlytics proves to be an ideal, safe and effective delivery agent for CAR-T treatment, the FDA may ‘cut some slack’ (my words), but don’t count on it … they are rightly very concerned that they “first, do no harm”.

Just my initial thoughts … and I’m sure that there are many here that can expand further, or perhaps counter.



Hi Mango @Mangoman605

Your caution in this area shows considerable commonsense. You have raised a number of good points that we should all consider. As they say … only risk what you can afford to lose.

All opinion only.