BrainStorm Cell Says FDA Meeting Provides Clear Path For Planned Phase 3b Trial Of NurOwn In ALS

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Stocktwits
BrainStorm Cell Says FDA Meeting Provides Clear Path For Planned Phase 3b Trial Of NurOwn In ALS

(RTTNews) - BrainStorm Cell Therapeutics, Inc. (BCLI) announced Thursday the completion of a productive meeting with the U.S. Food and Drug Administration (FDA) to discuss NurOwn, its investigational treatment for amyotrophic lateral sclerosis (ALS).

The primary objective of the meeting was to discuss key considerations for a Special Protocol Assessment (SPA) for a planned Phase 3b registrational trial for NurOwn.

As an outcome of the meeting, BrainStorm will submit relevant documentation as outlined by the FDA to support the SPA.

The ultimate goal is to secure the FDA's agreement that critical elements of the overall protocol design (e.g., entry criteria, endpoints, planned analyses) are adequate and acceptable for a study intended to support a future marketing application.

Tags: BCLI
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Rebound Anticipated For Singapore Shares

Rebound Anticipated For Singapore Shares

The Singapore stock market on Wednesday snapped the two-day winning streak in which it had gathered more than 30 points or 0.8 percent. The Straits Times Index now sits just above the 3,870-point plateau although it may bounce higher again on Thursday.
RTTNews | il y a 4 minutes
Malaysia Bourse May See Additional Support

Malaysia Bourse May See Additional Support

The Malaysia stock market has moved higher in three straight sessions, advancing more than 40 points or 2.7 percent in that span. The Kuala Lumpur Composite Index now sits just above the 1,580-point plateau and it may extend its gains again on Thursday.
RTTNews | il y a 34 minutes
Mild Rebound Tipped For Japan Stock Market

Mild Rebound Tipped For Japan Stock Market

The Japanese stock market on Wednesday wrote a finish to the four-day winning streak in which it had surged more than 1,400 points or 3.7 percent. The Nikkei 225 now sits just beneath the 38,130-point plateau although it may tick to the upside again on Thursday.
RTTNews | il y a 49 minutes
Win Streak May Continue For South Korea Shares

Win Streak May Continue For South Korea Shares

The South Korea stock market has finished higher in three straight sessions, collecting more than 60 points or 2.4 percent in that span. The KOSPI now sits just above the 2,640-point plateau and it's tipped to open to the upside again on Thursday.
RTTNews | il y a 1h 4min
Australia Unemployment Data Due On Thursday

Australia Unemployment Data Due On Thursday

Australia will on Thursday release April numbers for unemployment, highlighting a modest day for Asia-Pacific economic activity. The jobless rate is expected to hold steady at 4.1 percent, with the addition of 20,900 jobs following the increase of 32,200 jobs in March.
RTTNews | il y a 2h 4min
European Markets Close With Mild Losses

European Markets Close With Mild Losses

The major European stock markets finished moderately to the downside in cautious trade on Wednesday as benign U.S. inflation data prompted traders to pare back Fed rate cut bets for this year.
RTTNews | il y a 3h 40min
Swiss Franc Weakens Against Majors

Swiss Franc Weakens Against Majors

The Swiss franc fell against its major counterparts in the New York session on Wednesday. The franc edged down to 1.1182 against the pound and 0.8436 against the greenback, from an early high of 1.1117 and a 5-day high of 0.8324, respectively.
RTTNews | il y a 4h 1min
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