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TOPIC: Seeking Alpha Transcript of CC

Seeking Alpha Transcript of CC 10 Aug 2015 09:17 #4955

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Apparently they had a lot of problems getting something "meaningful" out, since the quality is rather poor, but alas one can recognize roughly what has been said .. :whistle:

Link to the transcript : Seeking Alpha transcript

Anyway- Hedge did already an excellent job in summarizing, so I refer to his summary in the other thread..

Just three topics which caught my eye whilst reading and present new approaches and a like...

Pre-launch
So in terms of the interim activities, there are some options for us, and we would like to expand on our early positive experience using prelaunch or named patient programs, which we've been testing out over the last few months. Named patient programs are permitted under EU Drug Legislation, but they’re governed by individual member’s states.
We've treated three patients thus far in a single country and although named patient programs are reimbursed for use of new technologies they do have some downsides in that they are used for only for specific named patients and they can have a significant administrative burden associated with them.
That can take time to fill that out for individual patients. But we really at this point in our technology development where we are at late stage clinical trials, but we’re not formally approved are really in the sweet spot for moving that forward and that can be a source of revenue going forward in Europe and we intend to leverage that as much as we can.


To my knowledge, in Germany such a pre-launch for an indication which is in clinical investigation, can also be done for a device therapy, but yes- probably only in Germany. I presume these 3 patients were French scleroderma patients and elsewhere- like in France- thats only with NEW tech EMA therapies being investigated.

The commercial strategy with scleroderma- proving a service and product and owning Celution
So that kind of leads me now to commercial model and this is what’s really cool for us, and why this is such a great indication for us. I think the fact that we have European drug approval and it opens up not only fast track because it’s orphan, but it opens up a possibility of maybe coming out of the device based commercial model and go into more a drug based model.
And here is how it might work; so we might not sell the device or the consumable, but we might have a clinical account specialist that would go right into the hospital where we’ve predeployed our device and consumable at really a very reasonable working capital investment, quite frankly. And then we would - they would take the tissue, they would give it to our technician and we would give them back the drug at the end of the procedure and then any extra drug that’s left over, therapeutic that’s left over, we take cryopreserve and then hold that for the patient to be thawed and then sent if they need subsequent treatment.
So in Europe and the US for scleroderma, we see a model that maybe allows us to own the means of production and then effectively sell a service as well as a drug to the patient at the bedside and that’s given a number of patients in the U.S., that 40 or so major scleroderma sites in the US we think that model makes a lot of sense.


With scleroderma patients being treated in specific scleroderma centers- of which there are 40 in the US- this model would make sense, since price differentiation is pretty easy, if you provide a service and sell the product on site.

Collaborations
We continue to get inundated is probably too strong a word, but we do get a number of reverse enquiries regarding partnering with institutions for cell therapy trials not only orphan indications, which are more niche indications, but also major indications that are in the urologic field, renal, erectile dysfunction, aesthetic, breast, crohn's disease, wound healing, hepatic disease and we think that there are potential roles for the technology in those apps and I think one thing that’s driving this, is the kind of a emerging conclusions from a regulatory perspective that just doing this in your backyard will not work, but with increasingly unified regulatory approach to cell therapy, the bar has been set high, and we set it


Ok ok- we had that before..institutions probably being universities and government institutions.. :bye:

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