Axel Mark (3624) · TargetRestated
Acquisition of 2022 EUAs by the Ascella Real Time System
First written in FY2021-Q2. 1 of 3 entries say "Softened", first in FY2021. Latest entry: FY2022.
3entries
2years
0from disclosures
How it moved
Same theme, other companies
Obtaining FDA EUA for the Ascella Real Time SystemA theme 1 companies write about · 0 as a headwind · 1 as a tailwind
No other company in this theme has enough history to compare yet.
Full recordFilings, disclosures and news, newest first
- FY2022RestatedAnnual report
「The healthcare product development company that is our partner is seeking emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its testing equipment, but」
Regarding EUA, the company continues to state that it is seeking authorization without specifying the year in which it will be obtained. - FY2021SoftenedAnnual report
「The healthcare product development company that is our partner is seeking emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its testing equipment, but」
The wording changed from the previous time-bound expression, “targeting EUA in 2022,” to an expression stating that the company is seeking EUA during the current fiscal year, with no specific annual target stated. - FY2021-Q2First statedAnnual report
「The funds raised in the seed round in which our company participated will be used for clinical sample measurements required to obtain EUA, with the goal of obtaining EUA in 2022.」
For the Ascella Real Time System, the company plans to use the funds for clinical sample measurements and has set a target of obtaining emergency use authorization from the U.S. Food and Drug Administration in 2022.