"SI says" validates a statement as much as "KK says" makes a statement invalid (Old McDonald - misspellt?! and his farm, different story). Yes, SI has an FDA approved product now, which gives his statements a tick of approval compared to KK, but how many sentences, statements and interviews started with "SI said" that turned out to be... let's say overly optimistic?
You say SI said 3D is the solution and in your opinion that makes it valid. We say that after a decade of development there is still no 3D therapy in clinical trials. You say SI said it is not needed - again, valid...
We say KK says Cymerus is A solution (there is more than one) - and we trust that he knows what he is talking about, although I appreciate
@JB1975 's opinion that unless there has been a solution to scale Cymerus (maybe 3D, maybe still 2D+?), it is not a validated commercial solution. It must be proven first and for that we are still awaiting word from FCDI that the manufacturing process transfer has finally been completed. Horse. Cart.
Btw, as I have posted many times before, there have been more than just the recent CR with use of fund being for manufacturing (3D).
I agree, at this stage only a partnership validates our Cymerus platform - and that requires clinical data. Horse. Cart. Again.
The current business model is to partner/license (or sell the whole shop), not to develop a therapy and apply for approval. That was also MSB's initial business model. Hopefully CYP can stick to that model and is not forced to file a BLA.
(20min delay)