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| Statement |
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| And the feedback that we've had to this point in time has been very good |
| So it's been very encouraging from the response that we've received from these committees |
| The feedback and progress to date gives us confidence that HEPZATO KIT will become the standard of liver-directed therapy care for metastatic uveal melanoma patients quickly after launch |
| The overall survival results clearly demonstrate the positive impact of treating liver metastases on patient outcomes with CHEMOSAT |
| In HEPZATO KIT FDA approval, we have been encouraged by both the medical oncologists and interventional radiology communities, motivation and stated commitment to incorporate HEPZATO KIT into their practices to treating patients with metastatic uveal melanoma |
| And our individual radiologists and medical oncologists are very happy to champion this and push this forward outside the regular scheduled meetings |
| We feel confident with our hub services, Gerard mentioned earlier in the call and are -- they're assisting with the coding -- kind of the coding forecast for the facilities and then it's up to them to see if that's beneficial for them |
| We think we have a good argument to go with us first |
| Unidentified Participant Very good |
| We are working with a well-established hub service with significant experience in both ultra-orphan diseases and oncology designed to design and manage this program |
| So we're confident that out of the 11 sites that Gerard mentioned, that we'll have five of them that will perform procedures by the end of January |
| Sounds good |
| However, based on interest and progress to date, I am confident that we will achieve at least five active treatment sites sometime in the first quarter, 10 by the end of the second quarter and 15 treating centers by the end of 2024 |
| Thank you, everyone, and have a good evening |
| Great |
| Great |
| And so that will be well supplied going forward |
| In addition, each team will be supported by a clinical specialist who will support the treatment teams in preparation for and during the treatment with the goal of ensuring patient safety and improving patient outcomes |
| Scott Henry Thank you and good afternoon |
| Yale Jen Good afternoon and thanks for taking the questions and congrats on the progress |
| That’s good to hear |
| For example, our new Director of Sales, Zac MacLean, comes from Boston Scientific and has over 20 years of experience leading teams in bringing new liver-based interventional procedures to market |
| Good afternoon |
| Good afternoon |
| That's very helpful and thanks a lot for the details and congrats -- again, congrats on the progress |
| So clearly, it's going to be a mix, but we think we have a sound argument because the liver is usually the life-limiting organ site of metastases and you can get a quicker read on whether you're getting efficacy when you go with us first |
| Thank you very much |
| David Hoffman Thank you |
| Really helpful |
| Thank you |
| Statement |
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| And unfortunately, since we're a very small player for this generic product and these nested manufacturers, we really are having difficulty moving -- getting them to move off of what they say is basically, here's your contracted lead times |
| I think I caught your comments earlier on the call that it's taking a bit longer than expected |
| So those are the two main concerns when you really come down to it |
| We expect there'll be some issues with experienced sites |
| This is an unusual situation |
| Again, it's going to be -- it's tough to predict |
| This won't be a problem longer term |
| One thing I am certain of is patients that we lost in the trial that withdrew because their blood counts have not risen to the level or is appropriate to retreat them, we won't lose those likely in the commercial setting because the doctor will just wait a few extra weeks |
| I think once we get past the $10 million revenue milestone that will bring more cash to the balance sheet, we'll be just short of being breakeven then on an EBITDA basis |
| So you run the risk of going too long with [indiscernible] before you really know whether it's working or not |
| Actual results may differ materially from those expressed or implied in forward-looking statements due to various risks and uncertainties |
| We have other sites that, again, I've used in term on multiple calls or one-on-ones herding (ph) cats where it's been very difficult to get an interventional radiologists and anesthesiologists and prefusionist all attending the case at the same time, which requires an airplane flight, et cetera |
| And again, it's kind of been what has been too encouraging about this is that we have -- its ultra-rare disease, it's lack of standard of care for some of these patients, and we're also at the right hospitals |
| We've been overwhelmed by the response that we've had and the two-way communications that we've had with each hospital to this point in time |
| Could it have been a little smoother perhaps |
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