Vericel Corp. (VCEL)

[hurley cruppers]

Getting excited about FDA meeting, just rereading the Q & A regarding Ixmyelocel-T from Q1-17 CC

https://seekingalpha.com/article/4071673-vericels-vcel-ceo-nick-colangelo-q1-2017-results-earnings-call-transcript?part=single

Kevin DeGeeter

Hey. This is Kevin. Thanks for taking my questions. Congrats with regard to the RMAT designation. Can you clarify with regard to the potential for accelerated approval? Do you anticipate that that could be based on the completed 2b study, or how should we interpret that language in the context of a large existing database around ixmyelocel-T?

Nick Colangelo

Yes. Thanks, Kevin. This is Nick. And I’ll start and I’ll turn the call over to Mike Halpin, who I’d like to introduce as our new Senior Vice President of Quality and Regulatory Affairs.

As I mentioned earlier in the call, the standards for getting the RMAT designation is, obviously, treating a serious unmet need and then preliminary clinical evidence indicating that the drug has potential to address that unmet need. In terms of the accelerated approval, it can be based both on surrogate endpoints as well as data from a meaningful number of clinical sites. So, we certainly believe that there is a basis for engaging with the FDA in discussions around an accelerated approval based on a Phase 2b study, as we conducted that study at nearly 30 sites in the United States.

Mike Halpin

So, I think our next step -- this is Mike Halpin, would be to have a type B meeting with the FDA to explicitly discuss the accelerated approval strategy with the Phase 2b results we currently have and the other clinical data that currently exists for the product and explore the pathway.

Kevin DeGeeter

And along those lines, can you just comment with regard to business development strategy for ixmyelocel-T in the U.S. and in other ex-U.S. jurisdiction, specifically Japan? Do you want clarity with regard to, for example, in the U.S. that may come from this type B meeting before pushing more aggressively perhaps and partnering, or are these sort of independent track considerations with regard to business development and regulatory strategy for ixmyelocel-T?


Gerard Michel

Kevin, it’s is Gerard. Certainly, assists and conversations we’ve been having and I think will continue the conversations, I do think though it would be an inflection point getting the information out of the type B meeting. So, right now, what we have is, the table set for a lot of opportunities in terms of accelerated approval, till we have the meeting with the FDA, we’ve been entirely clear what the path is. So, I expect accelerated discussions once that meeting has occurred.

Kevin DeGeeter

And then, just one last point of clarification with regard to discussions outside the U.S., I think some of us have looked at regulatory environments, for example, in Japan. I thought that there may be faster pathways to partnering in certain geographies outside the U.S. Is that kind of consistent with your current business development focus or should we think about the U.S. is now being perhaps a higher priority or faster path for potential marketing or partnering?