Spoke to one of the biotech analysts and he thought that because they are already approved for Specials, the manufacturing approval process should be faster than average as most companies do not have a specials program, so he is expecting news this month. That’s obviously just his personal opinion as they do not have coverage on OTC shares.
flip, where some get confused is that the FDA approval process for new and generic drug applications includes a review of the manufacturer's compliance with the CGMPs. Based on what I have seen, MHRA has a risk based inspection subsequent to submission. Is that your understanding?