Monday, November 20, 2017 11:15:26 AM
Sean Hannan (Needham)
Okay. Great. And then, also coming to the opportunities in front of you for your clients in looking at another two to four BLA filings, the course of the next 12 months and that there is now another potential commercial agreement that could materialize here. And please be patient with the question around this. If I were to reverse course about nine months ago and go through dialogue with your folks, I think the impression say a few months or quarters ago was that you know we'd be though about probably four BLA filings by this point. And so, if I aggregate the perception of the opportunities of 2017 plus 2018 and contrast that to what I feel, we may be talking about and looking at right now, it seems like it's a little bit more tempered on that BLA filing and commercialization front and it is not to go and throw water on what's been accomplished so far, what's been accomplished been quite a bit. But just trying to better understand you know that tempering and what may have changed and any color you can impart around that as a reflecting of where your client stand today?
Jerry Shelton
Yeah. Mark, do you want to address that? You are closer to it. (in other words . . . I ain’t touchin that one)
Mark Sawicki
Sure, happy to do so. Yeah, I mean, you are absolutely right, I mean what we do is when we put forward projections, is based on what our client base is looking at from a filing standpoint. And so, if you technically look at it from the beginning of the year, you know, there is actually two BLA filings that went commercial and we just had a third sBLA from Novartis that went through. So, you have in essence three filings from a commercialization standpoint. So, we're not too far off from that perspective, but there were a number of programs that we are supporting and as we talk about, it's always a net number, and so some of them have been either cancelled, so we did have a Phase III that was planning a BLA filing, the company ran out of money and shelved the Phase III program. You know we have not control over that. So, we do see things met from time to time, but we just – we track these on a rolling basis and we look at what these activities are and in every supplemental filing and some of these commercial launches, we're not going to – we could detail those out as separate independent events as well, but when we're talking two to four additional, we're really looking at either completely new indications or new companies from a filing standpoint. So, not sure if that answers your questions or not, but that's kind of the reality of it.
Does anyone know who was supposedly planning a BLA filing this year but then shelved an advanced phase 3 program just because they ran out of money? Sounds a little Trumpian to me. “Just believe me because I have more information than you.” And calling this Kymriah supplemental filing one of the BLA’s they were talking about before, but the 2-4 BLA’’s they are talking about NOW are completely new companies? Okay Mark.
Anyway, this is what made me think about Northwest Bio, but they actually shelved it years ago. And really? No other comments about this speculation?
It also doesn’t sound like Cryoport is going to provide details on the supplemental contracts for additional indications for Kymriah or Yescarta supposedly due to NDA’s, so investors are left guessing what the potential Novartis and Gilead contracts are each worth worldwide for all indications. $40M annually in a few years?
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