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Wednesday, March 03, 2021 1:42:53 PM
Mar. 03, 2021 1:34 PM ETBrainstorm Cell Therapeutics Inc. (BCLI)
By: Jonathan M Block, SA News Editor
The FDA yesterday took the unusual step of issuing an update with further details on last month's feedback that a high-level data summary of BrainStorm Cell Therapeutics' (NASDAQ:BCLI) NurOwn program for ALS did not provide substantial evidence to support a BLA application.
The agency said it was issuing the update because of the "tremendous public interest in this product."
The FDA said that none of the primary and secondary endpoints were met in the treatment arm.
For the primary endpoint, 27.7% of people in the placebo group responded compared to 32.6% of people given NurOwn -- the 4.9% difference was not statistically significant.
The FDA also said there was a "modest excess of deaths" in the NurOwn arm, though the significance of those death is unclear at this point.
Recent BCLI News
- Form S-3/A - Registration statement under Securities Act of 1933: [Amend] • Edgar (US Regulatory) • 09/24/2024 08:30:50 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 09/17/2024 07:32:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/16/2024 08:36:41 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 09/09/2024 04:15:04 AM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 08/28/2024 09:01:02 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 08/16/2024 11:00:19 AM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/14/2024 12:01:59 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/14/2024 11:15:21 AM
- Form PRER14A - Preliminary Proxy Soliciting materials • Edgar (US Regulatory) • 08/06/2024 08:59:18 PM
- Form PRE 14A - Other preliminary proxy statements • Edgar (US Regulatory) • 08/05/2024 09:11:53 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/30/2024 08:05:27 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 07/24/2024 08:05:18 PM
- BCLI Update - Progress Supports Our 10x Plus Value Range Potential • PR Newswire (Canada) • 07/24/2024 12:30:00 PM
- BCLI Update - Progress Supports Our 10x Plus Value Range Potential • PR Newswire (US) • 07/24/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 07/19/2024 08:05:57 PM
- Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation • PR Newswire (US) • 06/14/2024 04:01:00 PM
- Initiation - Potential 10x Return on Successful Phase 3b. Promising Post Hoc and Biomarker Analysis Underpins Our NurOwn® Clinical Effectiveness Expectation • PR Newswire (Canada) • 06/14/2024 04:01:00 PM
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