YmAbs Therapeutics, Inc. (NASDAQ:YMAB) Q3 2019 Earnings Conference Call - Final Transcript
Nov 13, 2019 • 04:30 pm ET
Thank you. Ladies and gentlemen, at this time we will be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Alec Stranahan with Bank of America. Please proceed with your question.
Hi, guys. Great. Congrats on the progress, and thanks for taking my question. My first question is on the pre-BLA meeting for omburtamab, have you had any additional interaction with the FDA since the scheduled pre-BLA meeting was delayed. Specifically, any color you can give us the rationale for converting it with general meeting. And I guess also what gives you confidence that the BLA submission will remain on track for 1Q '20? And then I've got one more. Thanks.
Thank you for the question. And again, it makes good sense to streamline [Phonetic] this up. First of all, of course, we tried to reach out to the FDA, to see if they would be able to provide us with some additional guidance. And that was not the case, they came back to us and said, [Indecipherable] and we would receive preliminary responses to the questions that we have raised in the pre-BLA meetings that we had submitted and we would be discussing all the topics that we wanted to discuss that has been raised in our pre-BLA meeting package. My interpretation of the outcome, and based on also, remember we have a ton of meetings that we've had with the FDA on this program. And the FDA has been very collaborative with us on the program and been very helpful also in those guidance and also in accommodating what is possible. Remember, this first indication is only addressing 80 patients to 100 patients a year in the US. So there is a limit to how much also the FDA would even require. They understand that they cannot expect the same as you would for a new industry coming to the US market.
And they have said numerous times that they will do whether they can to help us. And I think basically my interpretation is that they are giving us -- remember when you have breakthrough designations, you're entitled to have many meetings with the agency as possible [Phonetic] not just the standards pre-IND meeting in the Phase 2 meeting, pre-Phase 3 meeting and pre-BLA meeting. With the breakthrough designation, we have our two lead compounds, we can have as many meetings with the agency we want to, but we can only have one pre-BLA meeting. And after the pre-BLA meeting, and then of course go back, if you do not agree. But you cannot have a second pre-BLA meeting.
So the idea, I think is simply that they say, hey, that's a number of things here. We are granting you 1.5 hour of discussion with us to discuss these topics here, and we believe you may need more time for coming to an agreement with us on what needs to be done and kind of like fine tune in your filing based on