Ocugen, Inc. (NASDAQ:OCGN) Q3 2023 Earnings Call Transcript

Swayampakula Ramakanth: Okay, okay, I see. And the last question on 400 is, one is for regarding — have you requested a meeting with FDA and based on your own proposal, which endpoint could be your primary endpoint? If you can…

Shankar Musunuri: I’ll let Dr. Upadhyay answer that our CSO. Go ahead, Arun.

Arun Upadhyay: Thanks, Shankar. So we are considering a combinatorial approach and we have proposed that to the FDA and we are going to have a meeting with them this quarter and accordingly once we have alignment with FDA then we will update the market, yes.

Swayampakula Ramakanth: All right. Sounds great. Thanks for taking my question.

Shankar Musunuri: Thank you.

Operator: Our Next question comes from the line of Robert LeBoyer with Nobel Capital Markets. Your line is open.

Robert LeBoyer: Good morning and thanks for taking my question. I just had a follow-up on the Phase 3 for OCU400 and wondering if you have any information or could disclose how many patients you expect to be in the trial or what the length of follow-up is going to be for the patients?

Shankar Musunuri: Good morning, Robert. I’ll let Arun address that.

Arun Upadhyay: Yes, so we are planning in the range of close to 100 subjects in Phase 3 in 1:1 randomization and one year follow-up.

Robert LeBoyer: Okay, thank you very much.

Arun Upadhyay: Just to confirm it is 100, okay.

Shankar Musunuri: It’s 100 patients, Robert.

Robert LeBoyer: Yes.

Operator: [Operator Instructions] There are no further questions at this time. I will now turn the call over to Chairman and CEO, Dr. Shankar Musunuri.

Shankar Musunuri: In closing, I’d like to reiterate our unwavering commitment to groundbreaking science and clinical innovations in order to create effective and positively impactful therapies that are accessible to patients globally. As we continue to execute stated plans, we remain focused on delivering long-term value for our shareholders, who have supported us and for prospects of Quant’s seeking to be part of our story. Thank you and have a great day.

Tiffany Hamilton: Thanks everyone.

Operator: This concludes today’s conference call. You may now disconnect.