banter and General Discussion, page-4738

Ok , we actual aren't that far apart . Were you say no , I am at the point of saying "not sure " note however that I used the term "largely" So all I am suggesting is that the FDA would see this as a very significant improvement to what they were looking at in the last review. So I am confident that this alone should half the concerns of approval . This alone may have double our chances of approval !

By the way I would think that this information will be gathered by MSB and available for review by the FDA and possibly approved treatment sights. Ongoing real world data is going to be critical for future development . This is not new, the magic consortium have been doing this for years . Could be in the form of a P4 although it could also be simple made mandatory by a registrar. The register concept has also been discussed by high-level officials from the FDA in a fire side chat a few years back. .

Now I tend to take SI statements literary. We are going with the original potency assay that has been improved. How much improved and what strength the data is to support this is not really known . You your self have done a lot of research , many here have just been adding things that you have failed to take into account. Like above, you missed that MSCs therapies that are administered to those that respond is rapid and can be tested for at 7 days . Compounding factors that you have mentioned in the EAP become less likely to be involved as you are testing response much sooner. A response at 3 days rather than one at 28 or 100 days. Perhaps we could agree that we have improved our chances of approval by a further 40% of the 50% . Our chance of approval goes to being 70% better.

Now to efficacy, In the past two years SI has exclusively spoken about the much improved survival benefit we have established using the magic consortium prognosis scores. Not to much has been said about the benefit to those outside this criteria. Indeed he has suggested that the therapy would be priced in line with CART T cancer treatments , this suggests that the indication will likely include a limiting prognosis score. A reduced target population but a much more at risk group with no alternative treatment. Perhaps a further 50% improved chance of approval. Bringing the overall chance of approval based on the totality of the evedence to 85 %

There are other things that are worthy of consideration however as you can see MSB has come a very long way since ODAC and I believe the FDA could even suggest that there decision of issuing the CRL as brilliant. Bringing only the best to market.