Industry news, page-841

the FDA 'pitch' must be rock solid watertight

'The regulatory nuances of the 505(b)(2) pathway are often underappreciated. Therefore, investors and regulatory teams more familiar with novel products often believe that the approval of an improved drug will be straightforward, since it is already approved in a different form. This can be an overly optimistic judgement without appropriate and extensive 505(b)(2) regulatory expertise. Problems that are not encountered in traditional programs can arise with CMC, scientific bridging, and justifying data in the published literature, and the problems are compounded further with the level of complexity of the product.'

just a case of be patient and let the team do their work i think - to submit and receive a 'complete response letter' from the FDA is to put it mildy...not a good look ....with Mr Clark in the house and Big P watching on there must be zero ambiguities and zero omissions in the application

im just staying patient because these guys are top of their game