Hi chas,

Thanks for the warm welcome, I appreciate it :)

There is a ton of impressive knowledge on this board, was just trying to augment it w/ some regulatory firepower. It's the least I can do for all the great information I've gotten from you guys.

Looking forward to some good discussion as we approach submission time, and ultimately approval!

Yeah, this is accurate. I was citing the NDA timelines, where the 60 day waiting period holds, this is not the case (i.e. no 60 day waiting period) for sNDA submissions, which is what Amarin will submit for expanded label for V.

So 10 months for standard review from NDA submission, 6 months for priority review. I do think we'll be granted priority review, we'll have to see. Fingers crossed.

Hi dmiller,

You're welcome. And yeah, that was really a key point I wanted to communicate: a major filing like an NDA/sNDA is really a huge company-wide effort and doesn't happen overnight, not even close. I just know this from experience, and also thought it would be helpful to share industry benchmarks as well.

Your point is actually valid, I wasn’t aware of this designation for the MARINE NDA. I’m new to Amarin, and don’t have the full backstory like most of you longs.

That said, I still find it pretty lame you’re telling people I’m a fake account, but thankfully no one else is listening.

Thanks for the banter, but I will spend my remaining posts talking to folks who have engaged me in a more positive way.

Hi BB,

Yep, that is correct. I also think there is high likelihood we receive priority review from FDA, which would be great.

And yeah, as much as I'd love to see it, I don't think anything prior to February is realistic, and I think getting the submission out in February would be a very nice accomplishment in its own right.

Hi Marzan,

This seems to be a very hot topic here, as your the 3rd person to ask, and I'm afraid I'm not of much help, as I really don't know the history of Anchor at all. I jumped into Amarin shortly after R-IT topline was announced in September.

I'm happy to do some research here, and probably should know this stuff, having a pretty significant position in Amarin. Please feel free to send me any background information that would be helpful to get up to speed :)

Hi BioChica,

Thanks for the warm welcome, I appreciate it :)

Someone else also asked a question about Anchor sNDA, and unfortunately I don't know much of the story there. I am new to Amarin, having just jumped into this fascinating story this past October, after my friend tipped me off to the company, and the great R-IT results.

Let me do some digging regarding Anchor, and I will get back to you. It's good background for me to be aware of as well, as an investor!

Hi couldbebetter,

I would defer to others here, who are more qualified to assess probability of Amarin GIA vs BO than myself. But based on what I've seen/read, my opinion is that they intend to GIA in the US, for at least the short term (~next year or so), and find a partner in EU. This would allow them, in theory, to get expanded label/approval for V in US (and possibly EU, see below) and make them a much more attractive BO target.

Regarding EU filing: I think I mentioned in my earlier posts, I would love to see simultaneous US/EU filings. This is a very viable regulatory strategy, it just requires the resources and operations to pull it off. Hopefully they put some of that new capital they raised towards making this happen :)

Hope this helps.

Hi AVII77,

Thanks for the warm welcome, I appreciate it. There are a ton of experts here in the scientific realm, I was just wanting to give back by providing some input from a regulatory perspective; it seems timely, especially as we move towards the regulatory submissions.

Good question regarding the timing of the pre-sNDA meeting, unfortunately not sure I have a great answer there. I have typically seen these meetings happen ~3.5-4 months in advance of submission date, not a full year or so ahead. I'm by no means an expert on Amarin, and their whole backstory here, I just became an investor back in early October. I'll see what else I can learn regarding the pre-sNDA meeting held on 3/7/18, wasn't even aware it had happened.

As for your other question, everything I have seen, indicates an sNDA will be filed. This would be needed for expanded label. That said, a separate submission containing R-IT results could also be filed to the ANCHOR sNDA, or it could just be submitted under the upcoming sNDA, and the ANCHOR sNDA could cross reference it.

Hi BaaBaa,

I think this greatly increases Amarin's chances of being granted priority review for V, which would accelerate approval. I bounced this off a friend who works more in the regulatory strategy space, and he agreed as well.

Fingers crossed...

Vubru,

You're very welcome, glad you found it helpful.

Hi couldbebetter,

Regarding EU approval: this is obviously dependent on when the MAA is filed, and I'd have to double check the regs, but I think EMA review timelines are pretty close to in-line w/ FDA's. It also raises an interesting question: would Amarin do simultaneous US/EU filings? This is very common actually, it just comes down to the company's regulatory strategy, resources available to execute the work etc.

Much of the EU dossier is repurposed from the US one, the US submission is essentially "cloned" and regional nuance is worked in for the EU submission. The US dossier is actually the much more complex one. So again, very feasible.

Simultaneous US/EU filings and approvals, talk about some nice cash inflow :)

Hi BB,

Sorry for the delayed response, I was limited to 3 posts initially, and spent several of them fending off some troll who accused me of being a fake account.

To answer your question: I'm honestly not sure what impact, if any, this would have on submission, but it might facilitate a quicker review downstream on FDA side.

In terms of speeding up submission, there are methods to accelerate submission times, though it's hard to say without knowing much about Amarin's operations. The quickest I have ever heard of a marketing application being filed, is ~4 months from database lock of pivotal study, but that's really pushing it. Industry average is ~6 months. 4 months from DBL would put the filing somewhere in January. But I am thinking February is probably a more realistic aggressive timeline for Amarin's submission.

You’re right, never too late to learn something new. So let me educate you further, since you seem to be having trouble understanding the info in my original post…

REVIEW PERFORMANCE GOALS: NDA/BLA Submissions and Resubmissions:

a. Review and act on 90 percent of standard NME NDA and original BLA submissions within 10 months of the 60 day filing date

b. Review and act on 90 percent of priority NME NDA and original BLA submissions within 6 months of the 60 day filing date

Source: PDUFA REAUTHORIZATION PERFORMANCE GOALS AND PROCEDURES FISCAL YEARS 2018 THROUGH 2022 (same document you cited earlier, but that you seem to be having some trouble understanding)

https://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm511438.pdf

Further, per 21 CFR 314.101 – please pay attention: this is really key, b/c it dismantles what you are claiming regarding review times:

“The date of filing will be the date 60 days after the date FDA received the NDA”

Just to spell it out really clearly:

2 months (60 days after submission) + 10 months (standard review) = 12 month standard review timeline

2 months (60 days after submission) + 6 months (priority review) = 8 month priority review timeline

This is not to say the FDA review couldn’t be conducted quicker, but these are the stated FDA review timelines, as I originally posted, and which you are frivolously arguing with. If you would like to arbitrarily extrapolate a quicker FDA review, based on Amarin filings from 5+ years ago, by all means, be my guest. But if you worked in my industry, you would be out of a job very quickly, for making such foolish assumptions.

As noted above, this is verbatim from FDA and also codified in federal regulations, so really not subject to debate. Or in other words, checkmate. If you’re still confused, I suggest you immerse yourself in 21 CFR 314, you’d learn a lot.

Kind Regards,
OY187

Yes, I'm quite sure. Would you like me to send you a link to my LinkedIn profile?

As for those timelines, was that actual date of submission, or when FDA review "clock start" began? As I explained, there is a 2 month validation period prior to review clock starting. I'm guessing it was the latter.

Yes, I would agree w/ your assessment that Amarin is anticipating priority review based on their projected timelines they've shared. I've talked to some other folks within industry that work in regulatory strategy, and they agree there is high likelihood priority review will be granted. Let's hope so!

Great question regarding Adcom, I do not have a good answer there, but can check w/ some people who have more experience in that space than myself, and try and get us some additional info there.

On the topic of FDA/EMA regulatory submissions...

Hi all,

Been a lurker for a few months, but thought I’d weigh in on the talk regarding sNDA filing, as I have a lot of experience in the realm of regulatory submissions.

As others have recently pointed out, an sNDA is not a trivial thing, and certainly doesn’t happen overnight. It is a huge dossier, required in a prescribed electronic format for submission to FDA (and also EMA). Sponsor is required to submit very detailed information around label, Chemistry & Manufacturing, Nonclinical studies, and Clinical studies, among other things. This that takes many months and is a huge effort across authoring, programming/stats, publishing, etc and therefore is a large and very intensive cross functional initiative at any company, let alone a smaller company like Amarin.

On topic of FDA review, once the sNDA is filed, “standard” review takes 12 months (2 months for validation of dossier, and then 10 months for review. Priority review takes 8 months (2 months validation, then 6 months for review). A decision must be rendered by FDA at the end of the review period.

For some perspective: Industry benchmark for filing a sNDA is ~6 months from DBL of pivotal study (i.e. R-IT in our case) to submission. This is for well established companies, who have done many of these filings before, e.g. Pfizer, BMS, Amgen, etc. I don’t know the exact date of DBL for R-IT, but it typically happens just ahead of topline results. So with this, we could project an sNDA filing in early March, or perhaps in February, if Amarin really puts their foot on the gas pedal. IMO, expecting sNDA submission prior to February, is probably not realistic.

If priority review is granted, we could anticipate an FDA decision (i.e. Approval hopefully) in 4Q of 2019. One other thing I’ll point out: the format for MAA (marketing application in EU) is very similar to NDA/sNDA format in US. Many sponsors will perform simultaneous filings, and submit the US sNDA and EU MAA within weeks of one another, as much of the US dossier can be repurposed for sNDA. But this is really dependent on what the company’s regulatory strategy is. It would be an interesting question to ask Amarin.

I’ve worked in Regulatory for 17 years, including much of that time in regulatory submissions, and have filed many NDAs and MAAs for big pharma, so my opinion is qualified.

Hope this helps w/ some of the questions around the sNDA and to level set expectations. If there are any additional questions/comments, please let me know.

Thanks,
OY187