Immunomedics Inc. (NASDAQ:IMMU) Q3 2019 Earnings Conference Call Transcript
Oct 31, 2019 • 05:00 pm ET
Good afternoon, ladies and gentlemen, thank you for standing by. As a reminder, this call is being recorded today Wednesday, October 30, 2019.
At this time, I would like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics. Thank you.
Thank you, John. Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements may involve significant risks and uncertainties and therefore, actual results could differ materially from those expressed or implied on this call. For factors that could cause such differences, please refer to our regulatory filings with the Securities and Exchange Commission.
With us on the call today with prepared remarks, are Dr. Behzad Aghazadeh, Executive Chairman; and Usama Malik, Chief Financial Officer. Also on the call for Q&A is Scott Canute, Executive Director. Following the prepared remarks, we will open the call up for questions. Thank you. Behzad?
Thank you, Chau. Good afternoon, everyone, and thank you for joining us. As noted during our investor event at ESMO, we had a meeting with the FDA in late September to update the agency on our progress in addressing the matters raised in the CRL to gain alignment on the contents of the BLA and review the time line of our resubmission. The meeting with the agency went well as we continued our constructive dialogue. Importantly, there were no changes to our plan that we previously agreed to at the May Type A meeting, and we are targeting the resubmission of the BLA to occur in the late November, early December time frame.
Kudos to our quality and manufacturing teams, we have completed all BLA-related manufacturing operations at Morris Plains and after our scheduled and annual maintenance shutdown, we are already back up and running routine manufacturing operations in preparation for commercial launch subject to approval. I would like to take a moment here to express my gratitude and acknowledge the hard work put forth by our colleagues in getting us to this critical juncture.
Our focus now is on finalizing the BLA resubmission and to be ready for the pre-approval inspection when we resubmit. Since our review is with SEDAR, the FDA has officially 30 days to accept the submission before sending us an acknowledgment of receipt letter. However, the FDA has full discretion to accept our filing prior to the expiration of the 30-day period. In terms of the length of the review cycle, we do not want to speculate on behalf of the agency. Our goal has always been to optimize the approval time line by submitting a high-quality and easily reviewable BLA, while ensuring a structured and well prepared pre-approval inspection, thus allowing for a streamlined approval process.
Upon resubmission and anticipation of the potential launch, we will be looking to bolster our commercial capabilities and complement a significant portion of our U.S. commercial infrastructure we have been able to