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Re: SPA rescission guidance - ex hackerI didn't think you would be able to point to any language in the CRL to substantiate your claim that AMRN had applied for a label that included CVD risk reduction. Instead, you now morph your claim into an insupportable interpretation of the sNDA that would ignore the existence (and critical importance) of the SPA. Let's review. In reply to my post about how the FDA's rescission guidance is an attempt to justify their improper rescission of the ANCHOR SPA, you, in your earlier post, said, "the label AMRN was seeking for ANCHOR is what ultimately sunk them - reduction of CV risk in combo with a statin for TGs 200-499 (R-IT is TGs 150-499) - nobody knew in advance AMRN was going after a R-IT type label for ANCHOR, and if we had, I for one would have never bought the stock prior to the Adcom. It's in the CRL AMRN got for folks who don't believe me." I found your claim surprising, as a lot of people (I among them) did know that AMRN had not sought in ANCHOR a label that included "reduction of CV risk." Moreover, if AMRN had sought such language in the ANCHOR label, but not disclosed such, the company would be subject to significant liability exposure to anyone who relied upon its multiple publications of the indication it sought (see PR of 4/23/13). Your claim that if you had known AMRN was seeking "a R-IT type label for ANCHOR," you "would have never bought the stock prior to the Adcom. It's in the CRL ...." also is contrary to my factual understanding. Skeptical of that claim (and of your implicit attempt to portray AMRN as having not been forthright with investors regarding what it sought in the label), I reviewed the CRL, following your suggestion. I could not find there any language supporting your claim that AMRN sought a label that included "reduction of CV risk." I then asked you to point out any such language in the CRL. In your reply post, you then say that the language defining the patient population (and which included reference to CHD or CHD risk equivalent) "to the FDA meant "V + statin to reduce CHD risk." Seriously? You thus, in addition to using a plainly illogical interpretation of the sNDA's literal wording, overlook FDA's error (in ignoring, then rescinding the SPA) and transfer responsibility from FDA to Amarin (by alleging Amarin sought an indication for which it obviously did not have supporting data). FDA, before ANCHOR began, agreed with Amarin that Amarin would also conduct REDUCE-IT and would not even submit an ANCHOR sNDA until REDUCE-IT was well underway. That made quite clear that FDA knew there was/is uncertainty re whether lowering of elevated trigs using Vascepa would reduce CV risk; REDUCE-IT, not ANCHOR, would answer that question. Amarin made good on their end of the agreement and, at great expense, started REDUCE-IT. After ANCHOR was completed, the ANCHOR sNDA sought a label for reduction of "TG, non-HDL-C, Apo B, LDL-C, TC, and VLDL-C in adult patients with mixed dyslipidemia and CHD or a CHD risk equivalent." Both FDA and Amarin knew full well, from ANCHOR's beginning, including when the SPA was executed, that ANCHOR's endpoints' rationale included that such lowering might reduce CVD risk, but that such relationship was unproven and would be the separate subject of REDUCE-IT. Once ANCHOR was complete and its sNDA submitted, FDA ostensibly changed its mind about whether lowering elevated trigs might be a reasonable surrogate for CVD risk reduction and, as you say, framed the adcom question in a manner that essentially required evidence of clinical benefit flowing from effectively achieving the ANCHOR endpoints (trig reduction, et al). Lacking such evidence, the adcom voted to recommend waiting for such evidence. To conform to its actions at adcom, FDA unilaterally rescinded the ANCHOR SPA (on flimsy rationale). FDA's changing its mind (without valid scientific basis), not Amarin's seeking a label for which it obviously had no data, "is what ultimately sunk them." FDA's moving the goal post at the end of the game was unilateral and in breach of the SPA (which is why FDA had to rescind the SPA). Importantly, it was not predicated on any seeking by Amarin of a label that included that Vascepa would achieve CV risk reduction. Rather, FDA changed its mind that Vasecepa's reducing elevated trigs might be clinically beneficial. Everyone who was diligent in reading Amarin's PRs knew the indication Amarin sought in the label, and, according to the CRL, the language did not include CVD risk reduction. It is factually inaccurate to suggest otherwise. The wrongdoing here was by FDA, not by Amarin's seeking a label that the ANCHOR data obviously could not support. Finally, your suggestion that an sNDA worded without referencing the patient population's description as including CHD or CHD risk equivalent may have been approved is equally insupportable. FDA issued the CRL because it changed its mind about the reasonable possibility that lowering elevated trigs with Vascepa might reduce CVD risk (thus necessitating rescinding the SPA), not because the ANCHOR population was described as including people with CHD or CHD risk equivalent. Glad to hear your Lp-PLA2 is under control. |
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Msg # | Subject | Author | Recs | Date Posted |
2170 | Re: SPA rescission guidance - ex hacker | ex_hacker202 | 1 | 5/19/2016 5:58:51 PM |