Jeremy L. Dillon
RW Monitor
8/28/2015
The Nuclear Regulatory Commission’s readiness to conduct a timely review of Northwest Medical Isotopes’ construction permit application for its molybdenum-99 facility remains “the critical pathway” to commercializing the company’s business plan, Vice President and Chief Operating Officer Carolyn Haass told RW Monitor in an Aug. 12 interview.
As of last month, Northwest Medical successfully submitted its full construction permit application following a slight hiccup to its first part of the request earlier this year. Should everything run smoothly with the NRC, Northwest anticipates beginning construction of the Missouri facility in mid-2016.
With Canada set to stop government spending in 2016 on the National Research Universal (NRU) reactor, one of the world’s largest suppliers of moly-99 and technetium-99m, the medical isotope industry anticipates a shortage in the market in the coming years. This has attracted a string of companies looking to fill the void, with Northwest being the latest to make progress in its attempt to get its product to market.
To start things off, a lot of the other molybdenum-99 production companies have been pretty vocal about where they stand, so I wanted ask first off if you could provide an update to where Northwest Medical Isotopes currently is and where you see the company going?
As of today, Northwest Medical Isotopes has submitted our full construction permit application. We did the first part in February, and we did the second part in early July. One of the items I want to mention is that we did submit our first part back in November, but the NRC came back to us and actually did not deny us. What they wanted us to do was add additional information on the network of university reactors to Part 1 because they are considered a connected action. And they just felt they wanted a little more at that time. The NRC didn’t deny what we did, they wanted additional information. Thus, I actually withdrew it, and re-issued it two weeks later. That’s what occurred. It’s not like we were denied, and I think that is important for the community to know that.
NWMI’s preliminary design is completed for our radioisotope production facility, and we have initiated final design. In addition, a big success for us is that we are regularly producing six to eight curies from our concept testing. And, we are currently in technology optimization of everything for our facility. As you know, our siting decision has been taken, and it has been formalized with the University of Missouri at the Discovery Ridge research park. We have also finalized our network of irradiation suppliers. The reason we have a network is because we are looking at reliability reactors. We have the University of Missouri research reactor and Oregon State. We do have a third one, but we are in negotiations with them, so I can’t say who it is, but it has been finalized.
So with a lot of the organizational infrastructure in place, what is your timeline for moving forward now in order to get out of the regulatory process and get to full production?
There are several activities that need to be done. First of all, we need to get approval for our construction permit application. We have done a lot of up-front work with the NRC so that that can go as quickly as possible. But the NRC is still the critical path for our whole project. We have gotten our first round of Request for Additional Information (RAIs) on the submission, and they are doing their site visit in September. We would like to start construction in mid-2016, but obviously that will be up to the NRC. Our goal is to be in production towards the third quarter of 2017.
Are there potential problem areas that could derail the regulatory pathway?
The key area of concern for NWMI is the regulatory side. This whole moly-99 project is a heavily regulated industry with significant review processes. As I stated, the NRC is our critical path, and it’s all going to be based upon if they can get the proper people in there to review it in a timely fashion. I cannot predict it. I mean it concerns myself as well as my board about how quickly that is going to go. I will tell you that I was impressed that we have already gotten comments back on our part one submission. I mean, it took them four months, but at least I see them doing things and they are doing them a bit quicker than they have in the past. They’ve not done a permit approval like this in a long time, though, and they are learning a lot from other people and us.
How soon after regulatory approval and construction do you anticipate getting production up and running?
We are looking at about 15-month construction, so from whenever that date is, about 15 months into it. There are some up-front things we would like to do that support construction. We will have all our contracts in place, and we will be able to push the button and say go get that approval.
On the contract front, can you provide an update on that arena? Has Northwest Medical Isotopes secured some supply agreements, anything along those lines?
We are in the finalization of our supply agreements with our irradiation services contract. We have finalized our contracts with our technical team to do the final design, both from an architecture-engineering perspective as well as process, safety, criticality shielding, and our environmental side. We are in the process of down-selecting for our general contractor at the moment, and we hope to have that in place within the next three months because they need to be involved in that final design as well. We are actually very excited over that one.
And what about supply agreements? Once construction is finalized, have you done anything to get out here and actually set up agreements to sell the product?
We are in discussions with several entities, and that is business sensitive. We feel very comfortable with the position and path-forward that we are in.
As a follow-up to that, and it may be business sensitive, but how would characterize your financing and your backing right now?
What I would say on the financial side is that our financial model is complete, and we are looking forward to construction. But as I said, we are in the final design phase.
Going to the competition realm of this, with so many companies vying to get to market, what makes Northwest Medical Isotopes different from everyone else?
Well, one, our moly-99 that we are going to produce is indistinguishable from existing supply right now. There would be no change to the generators. There would no change to diagnostic modalities. We have a network of existing university irradiation suppliers, which can assure the supply, and we can also do surge capacity. That’s the nice thing about our facility. We are based on doing about 3,000 to 3,500 six to eight curies weekly, but we have the capability to do a surge capacity as well. Our target design was designed specifically for reactor safety. It can be used in any of our reactors the way it is set up. We also don’t do any dissolution of metal clouting, which is actually quite significant because it takes a step out of our technology when we actually start moving the moly. And, all our processes have been proven efficient, and we plan to recycle uranium.
The key thing is, and I will stress it again, that we have already proven to be able to produce curie quantities of moly.
Carolyn Haass will also discuss the status of Northwest Medical Isotopes and its effort to commercialize its molybdenum-99 business plan at the 2015 ExchangeMonitor RadWaste Summit, which is scheduled for Sept. 8-11 in Summerlin, Nev. The conference will include presentations from a host of government and industry speakers; registration and agenda details can be found here.
