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HDGabor,We don’t know of a case where the

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MedResCollab   Wednesday, 07/10/19 07:37:17 PM
Re: HDGabor post# 200955
Post # of 338682 

We don’t know of a case where the FDA never communicated to the sponsor of a priority review application whether they plan to hold an AC meeting or not. In every example we are aware of, it is either communicated by day-74 letter that “there are no current plans to hold an AC meeting,” or they mention preliminary plans to hold one then, or wait and fully confirm the AC meeting and date at mid-cycle communication CC (which comes “within 14-days after internal mid-cycle review”). We are also unaware of any cases in which FDA waits until mid-cycle comm to tell sponsor or confirm sponsor’s request for clarification that there will not be an AC meeting. Suppose it could happen, but unlikely. Thus, our >80% chance we are told by Amarin there will be an AC meeting and the date of the meeting, and soon (next week the latest).

The only possible deviation to this we can see is if the FDA held off on the mid-cycle review altogether (see section of guidance we posted), knowing they would be sending Amarin an Extension Letter, pushing the PDUFA date back 3-months, and with it the planned mid-cycle review date. They could deliver, along with this Letter, notice of preliminary plans or definite plans to hold an AC meeting, and if plans are definite also a date. Or, in this case (PDUFA extended), they can also wait until “within two weeks” after the new mid-cycle review date, which date would be about 4.5 months into the new 9-month total review, or mid Aug, to let Amarin know on AC meeting plans at that mid-cycle communication CC, which would then be in late Aug.

It is certainly a swirling web of info: if this, then that, and if that, then that and that, but no longer that or this... These reviews are complex.

On the ANCHOR biomarker data submitted with MARINE, FDA confirmed they didn’t even look at its efficacy data but only safety data during MARINE review. Reason being they did not have full ANCHOR dataset, and chose not to infer from study report only, even though it did contain top line biomarker data (see our “Why Didn’t the DMC Recommend the REDUCE-IT Trial be Halted?” section of our first CP). Prudent choice, in our view. Didn’t even touch it.

On why an AdComm, these are the three specific reasons given by FDA (except for all NCEs and BLAs, etc):

A review division may need AC input, for example, when: 1) the clinical trial design used novel clinical or surrogate endpoints; 2) the application raises significant issues on the safety and/or effectiveness of the drug or biologic; or 3) the application raises significant public health questions on the role of the drug or biologic in the diagnosis, cure, mitigation, treatment, or prevention of a disease. —FDA

Obviously, only 2) would apply to the Vascepa efficacy supplement. And it is by far the most common reason FDA holds an AdComm.

Best wishes HDGabor, and we hope that you are hedged.


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