YmAbs Therapeutics, Inc. (NASDAQ:YMAB) Q3 2019 Earnings Conference Call - Final Transcript
Nov 13, 2019 • 04:30 pm ET
the questions that you have raised, because we are the ones that ask questions to the agency about the package. So then this way they can give us this 1.5 hours of discussion, next week, at the meeting, and then we can go back and ask for a pre-BLA meeting. And then they have looked at our timing, and I mean dispatch placed [Phonetic] out of rolling BLA in December with the first part of the manufacturing in the preclinical package. But they do it in the beginning of February, the investment team will have overall timeline of having the lab as part of the CMC and the whole clinical package finished by the end of March. So, overall, it doesn't mean anything else, but it gives us to make a [Phonetic] time for discussion. That's at least my interpretation of it and that's the case, and I still believe that this is in line with what we have discussed with the agency previously. Then we should be finished with the entire BLA submission for omburtamab by the end of first quarter. So -- and again, remember, I mean, we have just updated the data from this Study 03-133 and seen an increase in the median overall survival. That is still potential increase in survival [Phonetic].
We have a patient group where everybody is doing to die from their disease. And we are curing 50%, more than 50%, and if those that actually dies, we can see that half of them dies from systemically that, not from disease in the brain, they still cure in [Phonetic] the brain. So this is a highly efficacious treatment for these case, and we've nothing else for them. So they have also looked at safety database now, a number of times where we have no indication of any significant safety issues, we see no grade 4, grade 5 safety issues, and very-very few grade 3 signals in terms of side effects for these patients.
So with all that in hand. I'm very comfortable that that the FDA and YmAbs understand the need for bringing this treatment out to patients outside of MSK and that's what's expected with Study 101 was about to show that we can treat patients in other sites, and we have done that, and we'll be sharing those data with the agency at the meeting next week. I think that kind of answers your question Alec.
Yes, that was very comprehensive. Thank you. And I had one more question actually on the next to the map data that was presented at SIOP in osteosarcoma patient, specifically the neutralizing antibody, human anti-human, I noticed in the poster that there was a roughly 37% HAHA positivity, which is higher than, I believe, previously this was 15% in neuroblastoma, and I mean it's roughly in line with what we're seeing in with Unituxin, but I was hoping to hear your thoughts on that. Thanks.
Yeah. One, I mean, the assay used for that evaluation