BrainStorm Cell Therapeutics Inc (BCLI)

[early_retirement2]

good question.. so, over the past year, the company has discussed/explored hospital exemption status in Israel and Canada. I'll start with Canada then move onto Israel.

I'd highly recommended you listen to the call from last week, just click the link and register. all of the company's most recent 2Q highlights are from a PR on August 14th (see their website).

Conference Call - http://public.viavid.com/player/index.php?id=125868


Canada - during the company's conference call on August 16th, they updated shareholders about the option to treat people in Canada. quick answer the CEO gave us was that the process to get approval in Canada would take as long as the US Phase 3 trial so at the moment, the company is focusing all efforts on phase 3. They said they're still in contact and discussions with Canada's ministry of health.

Israel - this has been very important as the company moves forward. currently, they're in negotiations with the ministry of health and still working to get hospital exemption status. the CEO wasn't too forthcoming with information during the conference call because it appears they're very close to an agreement. I think his lack of info was for legal purposes. the CEO said they would initially treat 3-4 patients and if the process and patients are ok, they'll move onto to treating others. Now the 50-60 patients is from patients who've already signed up to receive treatment. The CEO also stated in the conference call that if patients are treated this year, the company will be profitable in Q1 2018. Also, keep in the mind the company has just under $7M in cash and NO DEBT.. so, if they treat 5 patients, they'll be profitable. It won't be a lot but it says a lot about the company.

Phase 3 - for this process, yes, the enrollment period would take about 3-4 months as the bone aspiration will occur 5 weeks prior to the first treatment. don't quote me on this but when treatment is available during hospital exemption status, they're treating anyone who wants to be treated. I believe there's no enrollment, if someone with ALS wants to be treated, they'll have to pay for the service. I assume the company and hospital will take proper safety protocols and patients will have to sign waivers, etc. but I believe when a treatment is available under this status, it's like receiving regular treatment.

click link for patient update hosted by NEALS - skip to 18:30 of the video when they discuss P3 design and details. https://www.neals.org/for-people-with-als-caregivers/educational-webinars/nurown-clinical-development-program-promising-phase-2-results-phase-3-study

hopefully this answers your questions? let me know if you have anymore!