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Msg  2988 of 2994  at  7/13/2020 7:07:13 PM  by

tjinvest


 In response to msg 2985 by  muddyc
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Re: Help me out here

 
> 1) as always continuation of some sort of billing pass through for Omidria ... what would a considered investor be looking for here, some sort of payment schedule event?

CMS seems to have no interest in separate payment going forward, so likely passage of the NO PAIN Act would be required.  So far, the lobbyists haven't been able to stuff it into some "must pass" bill (didn't make it into CARES Act 2.0.), so it's sitting in committee, prospects unknown (i.e. awaiting more campaign "donations").  See snippet below for Earnings Call language, which I coincidentally just looked up:

> 2) continued rolling BLA submission of narsoplimab for HSCT-TMA, remind me is this just basically down to CMC now?

Not sure anyone knows outside the company.  I recall some SA commenter several months ago said it would take >6 months after the final CMC assay batch in order to submit NDA, so they guessed it would actually be more like June or July submission.  Let's hope this commenter was right (and more informative than this CEO will ever be).

> 3) some notions of COVID applications, I'm just not (and unlikely to) following that, am I a fool for not considering this?

There was a brief reference to some use in a handful of patients in Italy.  Nothing much stated formally.  But see snippet below for what was said:

> 4) the other indications, and the MASP3 pipeline off in the distance, is this 2025 and beyond? I know I just need to revist and put on some glasses read some and catch up, but I figured I would stir the pot here first. 

No clue, I'll let others respond.  At the development pace of this company, nothing besides Narso interests me.

Earnings call May 11:

The Non-Opioids Prevent Addiction in the Nation or the NOPAIN Act is a bill introduced in both chambers of Congress with increasingly strong bipartisan support. If enacted, it would provide separate payment for opioid-sparing treatments such as OMIDRIA for at least 5 years and would fix the disincentives that keep practitioners from prescribing non-opioid treatment alternatives in surgical settings. Just last Friday, a bipartisan letter signed by 16 members of the House of Representatives, many of whom serve on Energy and Commerce, a Committee of Jurisdiction over CMS was submitted to the House Democrat and Republican leadership, requesting the inclusion of the NOPAIN Act in the upcoming CARES 2.0 legislation.

Other administrative and legislative efforts are also progressing. While we remain optimistic that separate payment will continue, we are also working through scenarios to ensure that OMIDRIA will be a viable product that improves patient outcomes regardless of insurance payer, and that returns value to our shareholders even without separate payment from CMS for Medicare Part B beneficiaries.


And in Q&A:

Okay. Can you confirm whether narsoplimab or any of your products are being studied for the potential use in coronavirus?

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [14]

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Okay. Understood. Understood.

Look, I'll answer it this way. We're aware of the public information linking COVID-19 and the lectin pathway, specifically MASP-2. I think those data are publicly available. Those are clear to us. In fact, we had identified the connection between COVID-19, the lectin pathway and specifically MASP-2 prior to it being made publicly available. So I hope that answers your first question. Your second question, I think, was directed to OMIDRIA and what we think the likelihood of the NOPAIN Act being passed into law. Is that correct?

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [15]

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That is correct, Greg.

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Gregory A. Demopulos, Omeros Corporation - Co-Founder, Chairman, CEO & President [16]

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Yes. Yes. Look, it's interesting. I think that a lot of individuals might assume that all of the oxygen in Washington, D.C. is sort of sucked out of the room by COVID-19. And that's in large part a true statement. What is important there to understand, however, is that the number of vehicles moving through Congress has actually increased substantially with COVID-19.

And for a provision or bill like the NOPAIN Act, one of the most important components in getting that successfully through, as I understand the group that's leading that, which is Voices for Non-Opioid Choices is that you have vehicles. I mean, you have to have a vehicle to which to attach the provision. And given the increasing number of vehicles, I think, frankly, the likelihood of seeing that bill passed increases with COVID-19.

I think that there is -- as I said earlier, there is significant support and importantly, bipartisan support -- bipartisan support in both Chambers of Congress, in the House and the Senate and on the Committees of Jurisdiction. And in the House, those Committees of Jurisdiction would be Energy and Commerce. And Ways and Means in the Senate, it's the Finance Committee. So when you look at the support that you are seeing for this bill out of both chambers, you do see key members and leadership of those specific committees. And so I think all of that bodes well.




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