Indication intelligence, analysis and sector perception

BrainStorm Cell Therapeutics (BCLI) slammed by FDA for the “Lack of Substantial Data for Submission”

February 22, 2021 12:39pm

Dives -$2.35 or -3394% to $4.55

The FDA's initial review concluded that current data NurOwn P3 trial in amyotrophic lateral sclerosis (ALS) does not sufficiently provide the threshold of substantial evidence to support the marketing application.

Also, the FDA advised that this recommendation does not preclude Brainstorm from proceeding with a marketing application submission.

"Brainstorm will first consult with principal investigators, ALS experts, expert statisticians, regulatory advisors, and ALS advocacy groups to assess the benefit/risk of a BLA submission before making a final decision," said Chaim Lebovits, CEO.

35 companies, 1 interpreter!

Insight, foresight and recommendation

My motto … never leave an investor uninformed! I say today what others won’t, so you can do what others can’t.

My name is Henry McCusker; I endorse these opinions under my own name and with a subscription based membership.

Do you have an opinion you would like to share with us? We would like to hear from you.

Please e-mail us at hwm@regmedinvestors.com.

Editor and Publisher ... Henry McCusker enters his tenth (10th) year at RegMed Investors with past experience in sell-side analysis, buy-side management, corporate management and due diligence.

RegMed Investors (RMi) or Regmedinvestors.com content is the intellectual property of Henry McCusker. Any copying, republication or redistribution of RMI’s content, including by framing or similar means, is expressly prohibited without the prior written consent of Scimitar; who also shall not be liable for any errors or delays in content, or for any actions taken in reliance thereon. For additional information on other Scimitar media services or reposting please email hwm@regmedinvestors.com.

The information included above as well as individual companies and/or securities mentioned should be construed as guidance in RMi reviews.

The facts stated and the opinions given in this publication are based on data and information considered to be reliable and have been carefully worked into my qualitative analyses and prognoses. However, no guarantee can be given as to their fairness, accuracy or completeness.

Henry McCusker, the editor and publisher of RegMed Investors does not hold or have positions in securities referred to in this publication.