Sunday, April 28, 2024 12:32:20 PM
This would require the co operation of the health depts of those 3 countries . Say 1,000 patients in Germany with 500 each from France and Italy . .
Unless theres a change in the US regarding generic infringement ...reversal of Judge Du's decision etc the US market is break even at best .
Because of the patent extension in the EU ...it's IMHO the only market we should spend $ developing at this time.
To do that we need a buy in from the 3 major EU health dept markets mentioned above.
Why focus on Revasc rates following a PCI ?
Because it's one of the sub groups with the largest risk reduction and the economic benefit of this risk reduction is easily quantified.
Example ... assume there are 20,000 revasc cases following a PCI each year in Germany , Italy and France combined ...at an average cost 10,000 Euros each case ( less expensive then in the US ) = 200m Euros each year in cost to these 3 healthcare systems combined.
If SOC plus Vascepa reduces that event rate by 25% vs SOC alone in this patient population thats a savings of 50m Euro's .
Would this 50m Euros savings cover the cost of providing all PCI patients with Vazkepa following their initial PCI procedure ?
I don't know ...I'm just using this as an example of how AMRN could use a small focused trial like this to gain access to these markets ...assuming there was at least a 25% risk reduction in revasc rates
I'm not thinking of a rerun of the Reduce It trial . Simply a small focused trial in the 3 EU markets we need access to .
JMO
Kiwi
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