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    BIOVIC B   SE0008613731

BIOVICA INTERNATIONAL AB (PUBL)

(BIOVIC B)
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Biovica International : provides update on FDA application process

09/13/2021 | 02:07am EDT

Biovica, active in cancer diagnostics, today announced that the company’s expected timeline for its updated 510(k)-application to the US Food and Drug Administration (FDA) has been prolonged due to delay in response from FDA.

As Biovica is still waiting for required feedback from the FDA the company has not been able to submit its updated application yet. This means that the company most likely will not receive an answer from the FDA before the end of September, as previously communicated.

After submitting the response to the FDA, the expected outcome is either approval (clearance) or a request to submit more information.

“It is of course unfortunate that the FDA process is delayed. It is caused by the pandemic situation and unfortunately out of our control. We are ready to submit updates to the application but need to have patience and understanding about how the pandemic situation has affected processing times at the FDA. Thankfully, this is a short-term obstacle that will be overcome in due time,” said Anders Rylander.

© Modular Finance, source Nordic Press Releases

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Financials
Sales 2022 48,6 M 5,64 M 5,64 M
Net income 2022 -32,6 M -3,78 M -3,78 M
Net cash 2022 252 M 29,2 M 29,2 M
P/E ratio 2022 -45,9x
Yield 2022 -
Capitalization 1 317 M 153 M 153 M
EV / Sales 2022 21,9x
EV / Sales 2023 6,97x
Nbr of Employees 23
Free-Float 41,9%
Chart BIOVICA INTERNATIONAL AB (PUBL)
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Biovica International AB (publ) Technical Analysis Chart | BIOVIC B | SE0008613731 | MarketScreener
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 1
Last Close Price 46,35 SEK
Average target price 103,00 SEK
Spread / Average Target 122%
EPS Revisions
Managers and Directors
Anders Rylander Chief Executive Officer & Director
Cecilia Driving CFO, Head-Human Resource, IR & EVP
Lars Erik Holmqvist Chairman
Mattias Bergqvist Director-Clinical Development
Otti Bengtsson Gref Director-Research & Development
Sector and Competitors