The response data are then analyzed using a statistical model with important disease covariance. Can I ask one more question about the variance on SMA, PLS, or the ALS variance? ... EVP, Chief Business Officer at Brainstorm Cell Therapeutics Inc. Hackensack, NJ. Additionally, this trials run-in period allows us to quantify the ALS decline for each patient prior to treatment. Mike, next question please. And you can find a poster from this event as well as an audio recording of my presentation on Brainstorm’s corporate website. Welcome to Brainstorm’s third quarter 2020 earnings call and thank you everyone for joining us. We have a lot of pressure from patients to give them the treatment and then [indiscernible] between now and the readout will have to decide if we want to do it.
We have the approval to do it and we'll see. Thanks, Tony. Thank you.
The next question, please. Ralph or Tony can take this. Thanks, Tony. The BLA application for NurOwn will contain product and manufacturing information along with a summary of non-clinical and the clinical studies. Preetam? FDA has extensive industry guidance regarding the content that's required for a BLA, and that's what we're following. Tony is a recognized leader in regulatory affairs and brings years of multinational experience. We are working towards treating a maximum number of patients very quickly after an approval. Will it just be administered every eight weeks for the rest of the patient's life? We will now turn over the call for Q&A and Michael Wood from LifeSci will read the questions we have received. So please stay tuned. Additionally, we expect to launch in the U.S. first of course, and then followed by a similar approach in the EU5 and some of the other key global markets. Results may differ materially from those projected on today’s call. Ralph, do you want to take the first shot on this? So again, very excited to be here and do all I can to help with the therapy. We are working on the assumption that physicians will initiate and continue to administer NurOwn based on their experience.
So thank you. So Brainstorm’s patent portfolio includes granted patents in the United States and the Europe. I will now turn the call back to Ralph to complete the review of our clinical and regulatory activities. First of all, what gives your team confidence that the data release will actually happen by the end of November?
In September, we appointed Dr. Tony Waclawski as Executive Vice President and Global Head of Regulatory Affairs. I will now turn the call to Dr. Ralph Kern for a clinical and R&D updates.
The Phase III trial enrolled approximately 200 patients, randomized one-to-one to receive three doses of NurOwn or placebo administered over four months. We are currently engaged with the relevant regulatory agencies to finalize the design and conduct of this clinical trial and we will begin clinical trial enrollment once we receive final regulatory and logistical approvals.
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