Ann: Paradigm AGM Presentation, page-111

Maybe the term delay may have been more appropriate than "block", but it's more to do with the grey areas that exist with product registration. I'm no regulatory expert, but I know for example that the FDA have not yet defined specifically what is required for the DMOAD label. They may have alluded to, but they haven't set specific criteria (that i',m aware of) that needs to be met, which can be problematic when dealing with a legal, regulatory outfit such as the FDA.

When applying for product registration, specific criteria needs to be met, from which the FDA can request more (and more) data to be generated. Law firms representing pharma companies have a way of picking apart this criteria in a way that I only wish I could.

So while I think PAR have covered a lot of the requirements that the FDA will expect for product registration and DMOAD label, I would like to see PAR go full steam ahead on OA and start to operate in a way that indicates that it may not be all smooth sailing, since if they anticipate that difficulties may arise, then prepare accordingly (not after they arise), then we may just get across the line first with sufficient tail wind.

Just my views, dyor