I don’t buy the manufacturing argument as the reason things are slow, and I don’t think the Flaskworks system will be a huge hurdle. I expect there will be iterations that can be implemented to do this process, and I don’t buy that there would be some special hurdle for this treatment to implement it in this system.
But if they did not have Flaskworks, I think they’d still get approved, and be a company worth purchasing for a good amount.
Flaskworks was a brilliant acquisition, at a wonderful time, and adds so much more to the company’s potential than the market seems to understand, but not having it, in my view, was not a barrier to getting approved ever.
But having it, should be seen as much more significant than the market understands, IMHO.
As for CRL, the contract clause they have for engaging them for production actually kicks in UPON approval. So it is clearly still an option and would and could be a part of their application. That CRL is now part of a global company just gives them that much more to add to their potential for manufacturing as a fallback. I do not believe that at this time, manufacturing is a barrier to approval, but having Flaskworks validated at the time of review puts them in a different category, and that would make it more likely they will be viewed differently, IMHO, by all the relevant agencies, as a huge potential technology for all cancers. It just puts them at another level for prioritization and acceleration.