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ziploc_1

08/04/22 8:35 AM

#385162 RE: BioInvestor3 #385148

Bio...In the case of a combo with a Statin and Vascepa, a blister pack would seem to have the edge over a fixed dose combination.

1.It requires less research
2. It would be easier to manufacture
3. It could employ several different doses of statin combined with 4 grams of Vascepa
4. it would be easier to get FDA approval
5. It requires less investment of cash from Amarin
6. It further enhances the protection of the Vascepa EPA from oxidization...and thereby enhances shelf life

Pharmacydude

08/04/22 8:43 AM

#385164 RE: BioInvestor3 #385148

Bioinvestor
Maybe they are looking at a combination of the 2 ideas, like the suggestion I sent them 8 months ago:

https://drive.google.com/file/d/1toZTExgyvbSXJpqti8Q4WPL6Wzwuunl4/view?usp=drivesdk

Meowza

08/04/22 9:16 AM

#385180 RE: BioInvestor3 #385148

it only requires Phase 3



R-IT was a phase 3 study, which already showed that a combination of treatments with a statin plus Vascepa was safe and effective in reducing CVD.

This 'combination' has already received approval from the FDA...This IMO makes it unlikely that the FDA would now demand that Amarin repeat this study



Zip, you know I'm starting to wonder if KM knows what the hell he's talking about

lol!