RE: Pirfenidone and Nintedanib27 Nov 2021 12:34
Morning OBW
Yes, it would be nice to know a bit more detail in the near future. I'm interested to know why it will take 12 months to get to phase 1 readiness.
The sample manufacturing design should really be handled by a CMO with guidance from Nuformix, so I would have thought there should be little by way of certification processing required (CMO should already have the necessaries). In fact, I'm surprised that someone hasn't already been approached provisionally .
As far as recruitment goes, if everything is outsourced then they should need too many news bods over and above a new CEO.
So other than documentation, what needs to be done?
If it is further testing (i.e. toxicology) then does that pose a risk if it is currently unknown?