 Thank you very much for that review. That's very helpful. I actually work in the protocol service center for the NHGRI and we help with protocol development for IRB review and FDA submissions. So it's wonderful to know that other people are doing the same kind of thing in such an expansive way. So my question for Helena is considering the experience and and expansiveness of your shop, do you actually take advantage of the pre-submission process or do you all already know it all? You don't even bother. You don't need to go straight to the... Oh, I mean there is no way that we know it all. First of all, I second I'm not sure that someone working in an academic institution that has so many people from different departments contacting you can say that you know it all plus everything is always evolving. So I really would also say that our easiest submission and most smooth rights were when we contacted FDA. If anything, our challenge was to persuade investigators that because you know you always have these situations when someone who knows someone had a bad experience and they don't want to talk that really that's the best and if you want most cost-effective way because you're ensuring that you're not doing experiments that afterwards will not be accepted as a part of your submission. So pre-submission meeting is what we really encourage everybody to have. And I have a second question. There's been a lot of talk within IND universe about expanded access and I haven't heard anything about expanded access in regards to IDEs and I was just wondering do you even see that? Is that even a possibility within the IDE arena? Yes, we do have it at you. Can we did have a couple of emergency IDEs? We have that as a part of a training program and actually I sent some of the slides to Rebecca, so she might post. If you just a short description that it would be very similar logic and structure as expanded access for INDs. So what we had is two, three expanded access emergency IDEs, but not single patient, I mean compassionate use in the others. Yes, emergency use. Well, it's single patient, but it was emergency use ID. Can you give an example? Yes, just generally, what does it look like? I can give you two on top of my head. One was that we needed to have emergency use for Column that is not have the approved for cell sorting. There was a kid pediatric patient coming to Duke and so it was emergency within a few days for which we had it unauthorized to in order to provide cells for a patient for cell therapy we needed to make this unauthorized use of Column for cell sorting. So that was one example and the other one that there was a cardiac cardiac patient. So the device itself was already run under an IDE, but in different indication for different situation. When entering the OR, a physician knew that this might not go well and they came with that device kind of prepared that they might need to use that as a life-saving treatment, which it was. In both cases, so these were two simple examples that I can remember. I'm sure there were more, but these are two that I was involved at least. What I can say in both cases, it was very important that we contacted IRB and let them know, give them heads up, and we do have emergency IRB number. I'm sure that every IRB has it and there is also on the FDA website emergency number or something like that. Maybe it's not called emergency, but something like that number that you can call and the real person will either answer or return your call in a very, very quickly, because actually for that first scenario that I just, or case that I just described, it was like Friday, it was catching weekend, the kid was coming on Monday, so we really try to solicit some sort of feedback. It's not approval, but at least you try to let FDA know what will be, what's going to happen. Thank you. A while back, some folks at CDRH collaborated with some folks in the Clinical Proteomics Research Network at NCI to put together a publication that was basically a model pre-IDE or model IDE submission that was then published in the Cancer Research Journal, which is something that we've been able to point people to, you know, to give them an idea of what's involved if it's a whole new idea for them. Any thoughts about doing that for NGS or for any other platform? Yeah, so actually that case was a Mach 510K, so a Mach IDE would be even easier, but yeah, we've just, that's something we've discussed and just, I do think it would be good. I mean, I think it sort of illustrates one of the challenges, which is that it is, you know, because IDs are not public, there are no examples, so when you're starting to work on it, you know, you have no template. You don't have an example, so to the degrees that we can get even a, you know, a contrived example out there, I think it would be very helpful. So I think that was something we've discussed and, you know, certainly think about, you know, trying to get one of those going. I think it's a good idea. Are there any online questions? Anyone else? Perhaps we can take our hypothetical case studies and make them into the hypothetical Mach ID. I'd rather get them as a Mach one than a real one. All right, thank you to our speakers. Just a quick wrap up of the day. I think we, I think this was a pretty successful and informative workshop. All of the materials will be available online, including the supplemental materials that were mentioned throughout the day. We'll get those up as soon as possible next week. We'll be creating a summary of the workshop as well that will be available. I'd like to thank all of our speakers who traveled and we're all on all of our pre-workshop calls, our colleagues at FDA. And then finally, it takes a lot of people to put a workshop like this together. There was a lot of NHGRI staff involved. We borrowed from different branches, the genomics healthcare branch, the communications people who arrived at 6.30 this morning to set up for the webcast and also finally the entire policy branch who was all hands on deck who helped prepare early and were present today. And then finally to Rebecca Hong, who there would be no workshop without Rebecca. So thank you everyone and miss the traffic. Enjoy your weekend.