Another stellar update – in my opinion of course.There is no...

Another stellar update – in my opinion of course.

There is no doubt that this is a very complex update. I personally think that the market is sleeping on the significance of this update.

Some of my key takeaways:

1. This trial is proceeding with PRE-chemotherapy patients only. This was announced sometime ago. The FDA have given fast track for this product in the PRE-chemotherapy setting. These patients should be the focus of this update, as it will be these patients moving forward etc. If and when this product gets to market under the current parameters of the FDA’s fast track designation – then it will be for PRE-chemotherapy patients

2. This announcement specifically breaks up the statistics between PRE-chemotherapy patients and POST-chemotherapy patients. Given the trial is moving forward for PRE-chemotherapy patients, there is an obvious reason for this.

3. SallySet is onto this. She has set out the PRE-chemotherapy statistics. I won’t repeat them. But I will add, most of these stats are from 1 dose only.

4. There have been two complete responses. I think it is set out as only having been 1 complete response in the announcement, because 1 of those responses was within the trial parameters, whereas the other was due to a second dose through the EAP.

5. But the key takeaway is that both of the complete responses were in the PRE-chemotherapy setting and with two doses (1 patient at 12gbz and the other at 8gbz).

6. Several of the PRE-chemotherapy patients were pre-treated with actinium based radioligands including 1 of those patients in combination with a lutetium177 therapy. Yet these patients still made it into our trial…and one of them now has a PSA80 following two doses at 12gbz.

7. Some fair comments are going around about the reduction from 12gbz to 8gbz in the cohort expansion stage. On the face of it, it might seem a bit peculiar. But let’s think about this logically. These people are being dosed with radioactive material (we reduce the dosages to numbers and this fact is perhaps lost on us from time to time). If you can elicit a complete response with 8gbz in a PRE-chemotherapy patient – why do you need to go up to 12gbz? Isn’t it likely to be safer for the patients to have, say, 3 doses at 8gbz rather than 2 doses at 12gbz?

8. Let’s think about this from the FDA’s perspective. You have this little thing called breakthrough designation at your disposal. Presumably you might want to get this product to market because it appears that it will make a material difference in cancer sufferers’ lives. Is it going to be quicker to get it to market at 8gbz, where you have already seen a complete response? Or is it going to be quicker to get it to market at 12gbz, where there has been a complete response, but of course, the higher the radiation dose the more issues that there could be etc.