Washington, D.C. 20549





Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934


Date of report (Date of earliest event reported): November 1, 2019 (October 31, 2019)



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230 Park Avenue

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Item 8.01.            Other Events.


In the afternoon on October 31, 2019, we received an e-mail notification from the U.S. Food and Drug Administration, or FDA, that, upon their review of our omburtamab pre-Biologics License Application, or pre-BLA, meeting submission, our pre-BLA meeting with the FDA, which was originally scheduled for November 2019, has now been converted to a general guidance meeting. The FDA did not indicate a reason for this change or provide any additional information, although we are currently seeking additional information. As a result, we now expect that our rolling BLA submission for omburtamab, which we intended to commence in December 2019, will not begin until after a new pre-BLA meeting has been scheduled. Our pre-BLA meeting could still take place in 2019, or may be rescheduled for the first quarter of 2020.


We remain confident in the contents of our pre-BLA meeting submission and do not believe that this change in the timing of the pre-BLA meeting with the FDA will impact our previously disclosed and anticipated timing for our complete omburtamab BLA submission, which we still expect to complete by the end of the first quarter of 2020. As previously disclosed, we expect to have completed all required components of our anticipated BLA filing by the end of the first quarter of 2020, and expect to have the flexibility to file our BLA either via a rolling submission or via a single submission ahead of our expected completion date at the end of the first quarter of 2020.  In addition, we believe that the overall commercialization timeline will not be affected.


As previously announced, in a pre-BLA meeting for naxitamab we reached alignment with the FDA on an accelerated approval pathway for naxitamab and intend to begin submission of a rolling BLA for naxitamab in November 2019. We still expect to begin submission of the rolling BLA for naxitamamab in November 2019 and complete it in the first quarter of 2020.






Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.







Date: November 1, 2019


/s/ Thomas Gad



Thomas Gad



Founder, Chairman, President and Head of Business Development