Actually Musky, I don’t know and want to avoid speculation since this could be closely related to IPCI’s filing as well. I am hoping whatever product related issues it could be (perhaps food effect related as this is a growing hot topic since Pfizer’s product failed this aspect that they may not have had as much awareness to prior to their filing) IPCI has already addressed it through their studies, and any technical issues with the filing (perhaps labeling as ADF labeling is rather new as well was part of the issue but that’s not confirmed either) IPCI can learn from prior to their filing. Even though ELTP held a call on the 18th to discuss the CRL, no info has been released yet as far as I can tell, but should be released sometime soon and we can see if that has any indication on IPCI’s filing. There is a lot of chatter on the ELTP boards, but nothing with solid information so I still refrain from speculating along with them.
Perhaps when ELTP’s filing issues are released it helps IPCI ensures their filing meets FDA standards, but I believe IPCI has already worked closer with the FDA thus far in their product development to address FDA requirements, so they should already be fully aware of any potential holds up and how to address them prior to filing. This abuse deterrent formulation addresses a huge social issue, and the FDA is doing all they can to get products like these to market, so it makes sense that they would have been very clear when working with IPCI thus far. We will see if there is any potential impact to IPCI’s filing once the ELTP CRL info is released, but I wouldn’t think so prematurely.
