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doogdilinger

02/10/17 3:01 PM

#23586 RE: fabius #23585

Would be awesome if Rexista partnership got announced prior to Dr Odidi's presentation next month.

Would love to be a fly on the wall at IPCI these days.

If there is a lawsuit coming from Purdue it has to occur within 45 days of IPCI receiving FDA acceptance of their Rexista NDA...so logic would suggest that IPCI will want to secure a Rexista partnership sooner rather than later now that the FDA's accepted their Rexista NDA submission...but only IPCI and their potential Rexista partner know the status of any ongoing negotiations and timeframe involved to closing.

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Tekterra

02/10/17 3:17 PM

#23589 RE: fabius #23585

Having a manufacturing site in the US is a must once they get to the point of having multiple drugs out in the market. They won't be able to supply the market efficiently going over the boarders. And, it's not cheap transporting long distances.

Having a third party manufacturing your product risk having your technology stolen, and your cost becomes higher too. Assuming MNK start marketing all three ANDAs in both Canada and US in the future, IPCI will need additional facility. Especially for drugs that can't be imported into US like Rexista.

I am not sure how they are going to partner Rexista. They have to show the partner how to manufacture Rexista using nPPPODS. Manufacturing control looks like a lengthy process with FDA to gain final approval too.