AB Science announces that Health Canada has granted eligibility for reconsideration request for masitinib in ALS [Yahoo! Finance]
Cytokinetics, Incorporated (CYTK)
Last cytokinetics, incorporated earnings: 3/3 04:00 pm
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Source: Yahoo! Finance
Paris, 3 April, 2024, 6pm CET AB Science SA (Euronext - FR0010557264 - AB) today announces that Health Canada has granted eligibility for reconsideration request for masitinib in amyotrophic lateral sclerosis (ALS). The reconsideration process will re-examine, with new assessors, the decision based on information that was included in the original submission. A Notice of Deficiency-Withdrawal (NOD/w) was issued on February 19, 2024 by Health Canada regarding the New Drug Submission (NDS) for masitinib in the treatment of ALS. The intention to submit a reconsideration request was based on the arguments summarized in the press release dated 26 February 2024. Health Canada and AB Science have held a meeting to discuss the reconsideration process. AB Science is working closely with the agency to facilitate the review of masitinib conditional approval in ALS. AB Science has 45 days to file the reconsideration request. The pivotal argument is on the treatment of missing data. Variou
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CYTK
Earnings
- 2/27/24 - Miss
CYTK
Sec Filings
- 4/26/24 - Form 8-K
- 4/25/24 - Form 4
- 4/25/24 - Form 144
- CYTK's page on the SEC website