You have right we could not judge on Ajax credibility, maybe he got false information from his source. It’s not help if we talking about the credibility of anybody instead to analyze his statement.
My “problem” with the current statement ( FDA put back the SPA on the table and was open to approve =200 mg/dL and <500 mg/dL with warning label, but Amarin rejected it:
a.) How could they modify the SPA after the end of study? Why is it SPA and not sNDA? (PDUFA and approval is of sNDA and not of SPA.
b.) Amarin said several times that in their indication - Vascepa 4 grams per day is indicated as an adjunct to diet and in combination with a statin to reduce triglycerides, non-HDL, Apo B, LDL, total cholesterol, and VLDL in adult patients with mixed dyslipidemia and coronary heart disease or coronary heart disease risk-equivalent – it was only a target population and they are running Reduce-It for the proof. So, never mind how you interpret the original wording – let’s say reduce CVE, FDA:” “Although the indication strictly speaks to reduction in lipoprotein levels and improvement in numbers, this indication for this population certainly implies that one should expect cardiovascular benefit from treatment.” – I do not see a reason why Amarin refused the offer which equal with their interpretation of the indication – no CVE
c.) On the other hand FDA said that the only reason to treat these mid-range triglycerides is to prevent heart attack, stroke, and death. “ … companies wanting to target this lower range of TG, it was clearly with the goal of selling it to reduce the risk for cardiovascular disease” and made the mentioned offer to Amarin … (?)
It looks like all party did the opposite what they said .. FDA would like to approve without proof, Amarin did not accept their targeted indication.
It’s not logical for me.
And finally, yes: currently the top priorities are increase revenue / script and decrease cost since this two elements only which 100% depends on Amarin. For all other – appeal, legal case, etc. – they need at least one other party involved.
