Absolutely no one has oral abuse labeling claims and the entire Rexista AdCom docket provides a multitude of references into several more studies IPCI can continue to undertake/complete post approval to secure additional abuse deterrent claims like Nasal and Oral.
And the bottom line right now is that this Wednesday IPCI can and will secure an Adcom approval recommendation on Rexista and continue with all the additional studies as outlined in the AdCom docket while their legal team is continuing to resolve/deal with settling the Purdue lawsuit.
From poring over the company briefing docket logic clearly reflects that the FDA already knows IPCI has plans already in motion behind the scenes to complete additional studies and secure additional abuse deterrent labels.
Why would all the additional studies be in the submitted company briefing document if IPCI believes they can't get other elements of the file FDA approved!
And the Rexista intravenous results are extraordinary to say the least!!!
Which is precisely why IPCI is pursuing the AD label claim for the intravenous route...which as everyone knows is the most dangerous route of abuse!!!
But regardless of all the above and todays misinformation campaign spread from India...as I've stated for the past several months leading into Rexista AdCom...IPCI will fly through Rexista AdCom this Wednesday and receive a unanimous recommendation for approval...and then all the broken record predictions of supposed Rexista AdCom failure will simply shift to a whole new realm of moving target complaints...and mark my words that's exactly how things are going to play out!
Noticeably absent from all the ongoing Rexista AdCom banter is all the false bravado about how it was supposedly going to be proven at Rexista AdCom that the blue dye in Rexista would supposedly turn everyone into a blue smurf and kill them hahahahahahahhahahaa