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AngeloFoca

09/19/16 3:16 PM

#17802 RE: doogdilinger #17796

Excellent Doog - thanxs.

My guess is that Oxtenda will take the same path as Rexista did.

Extensive Phase 1 studies going directly to a Phase 3 study consisting of Bio Equivalency data.

We've been claiming that Rexista did/does not need a Phase 3 study... when in fact it did... it simply took the form of BE tests... it relies on objective data rather than a subjective opinion where subjective opinions are known to vary extremely.
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Samsa

09/19/16 4:51 PM

#17808 RE: doogdilinger #17796

Doog...there you have it. now one just makes their own assumptions. mine was and still is, if you can go the simpler route of an NDA-S why not? Yes, you will still have whatever studies to do the FDA requires but at least you dont have all the costs associated from square one as an NDA. therefore, since it can be filed as an NDA-S one must include discussions about Podras in any deal for Rexista. so its all hinging on them getting the patent number. but hey, if people want to think the company would rather file a separate NDA, then my question is, who do you think would really want Rexista 1 ? why pay big bucks for original Rexista if IPCI is just going to come out in two years with something better? logic dictates any partner would want dibs on Podras. but that's just my thought. sorry been away all day and just now catching up to see what I missed LOL
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mopar44o

09/19/16 6:11 PM

#17811 RE: doogdilinger #17796

You should write an article on Seeking Alpha about your brief conversation.