Sam, I don't know the laws and regulations either, but if what you're saying is accurate, IPCI would in fact be announcing a partner next week. this basically is saying that IPCI and partner have committed and submitted application to FDA which FDA accepted the application and manufacturing site.
I was looking up CMC part of the NDA, and IPCI does need to provide manufacturer name and address. They are also required to provide data on manufacturing and quality control that shows the product is effectively replicated reliably compare to lab test version at the manufacturing site.
It sounds like IPCI is required to provide this data to show that Rexista manufacturing process is reliable. This could have been one of he reason for the delay in filing the NDA. Which means, they can't really provide this data if they don't have a manufacturing site.
Now, the guideline also said that if during the review process, anything related to manufacturing should change that would affect the quality of the drug, IPCI would need to inform FDA.
It said nothing about you can't change manufacturing site during the review process. It said if any changed FDA needs to know and likely additional inspections and data needs to be submitted from the new site to show everything will be fine to make the product.
IPCI could have contracted a third party manufacturer in the US to provide this data for the NDA filing. One would hope that this manufacturer would also sign a deal with IPCI to sell the product upon FDA approval. Otherwise, IPCI is just paying a fee for the required manufacturing data, which makes no sense if all they are looking for is getting FDA approval without a third party to sell the product.
Apparently, IPCI disclosed nothing about a manufacturing site for Rexista all this time. And, it sounds like a partner is not set in stone unchangable after the NDA has been filed. So the inking of the deal isn't necessarily required as part of the NDA filing and upon acceptance.
So, we will know in a few days whether or not the current manufacturer who helped provided the data for NDA filing will be a commercial partner.
