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Wednesday, August 16, 2017 2:04:15 PM
http://public.viavid.com/player/index.php?id=125868
Summary
1. Phase 3 - CEO said with the $16M grant and $7 million in company cash, the Phase 3 trial is fully funded.
2. Phase 3 schedule - CEO said there's been concerns about the trial initiating for the second half of 2017 in previous PR's. CEO said the P3 trial is on schedule and will be available on ClinicalTrials.gov soon. The company has no control on when the information is available ClinicalTrials.gov.
3. Phase 3 center locations - all three hospitals from P2 study are involved and three new sites as stated in earnings PR. need to finish up administrative tasks as each site has different protocols for trials. total of 6 centers will be a part of P3 trial.
4. Technical Transfer - finalized by end of September for all technical transfer to City of Hope. PR will be released when this is completed.
5. New VP intro Mary Kay Turner
6. Phase 2 results will be published in public journals
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Shareholder/Investor Q&A session - I don't recall each question but I did write down answers to what I thought were most important.
1. Question about enrollment - Hundreds have signed up and screening has begun
2. Question about hospital exemption status in Israel and Canada;
a. Israel - can't comment on details but very close. if approved, initially 3-4 patients treated and if OK, they'll treat approximately 50-60 patients. this will make the company profitable for 1Q18. by reviewing 1Q18 revenues, investors will know the cost of treatment.
b. Canada - in discussions but nothing definite. possible approval would take about the same amount of time of P3 trial. still talking to Canada but at the moment, all effort on P3 trial.
3. Question about large Pharma collaboration - more than one large company has approached BCLI to collaborate but company said "not ready to comment."
4. Question about efficacy compared to recent ALS drug Radicava (edaravone) approved - CEO said their (edaravone) subgroup was smaller than BCLI's P2 group and NurOwn's 1.5 point increase per month yielded better results than Edaravone.
5. Question about trial length - Trial length from beginning to end approximately 18-21 months
Recent BCLI News
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- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/16/2024 11:00:19 AM
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