BIOVICA: FDA-PROCESS FÖR DIVITUM TKA SENARELÄGGS CA 90 DAGAR. Publicerad: 2021-01-18 (Direkt-SE)

Vi anser samtidigt att det faktum att vägen framåt i FDA-processen nu klarnar är ett framsteg och då det är en retrospektiv analys bedömer vi tidplanen som trovärdig. Som bekant tog Biovica in omkring 57 MSEK i en riktad emission i våras och bolaget hade 68 MSEK i likvida medel per den 31 juli 2019.

BIOVICA 2 september 2019 FDA-process klarnar Biovica klargör planen för att kliniskt validera DiviTum inför ansökan om marknadsgodkännande i USA. Det ger en viss försening jämfört med tidigare mål vilket vi dock anser har legat i korten en tid. Vi ser lösningen som lovande och trovärdig. Biovica har under sommaren haft interaktion Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. FDA resumes review of DiviTum®TKa submission.

Biovica fda

Biotage · Biotec Pharmacon · Bioteknik · Biovica International B Fastpartner A · Fastpartner D · Fastpartner Pref · FastPassCorp · FDA Biovica provides updates on FDA application Uppsala, Sweden, March 10, 2020. Biovica, active in cancer diagnostics, today announced that the company intends to submit an FDA application for market approval of DiviTum in the third quarter of 2020 and not as previously announced in mid-2020. Biovica’s FDA submission will proceed to substantive review Biovica, active in blood-based cancer diagnostics, today announced that the company’s 510 (k) submission to the US Food and Drug Administration (FDA) for the blood test DiviTum®TKa will proceed to substantive review when the COVID-19 related pause ends. Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510 (k) submission with the U.S. Food and Drug Administration (FDA). “The 510 (k) submission is a major step towards bringing DiviTum®TKa to patients and we look forward to working with the FDA to achieve clearance of DiviTum®TKa. Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510 (k)-submission for DiviTum®TKa.

Biovica International är ett läkemedelsbolag i kommersiell fas som inriktar sin forskning mot behandling av solida tumörer. Bolaget utvecklar metoder för mätning utav cellproliferation, där …

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510 (k)-submission for DiviTum®TKa. “This is fantastic news on our journey to make the test available to US patients as early as possible. Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa.

2021-01-16

19 mar 2021 Biovica expects a decision from the FDA, and a US commercial partner, before the end of Q3. As a market clearance in the US seems to draw Biovica, active in cancer diagnostics, today announced that the analytical validation of the blood test DiviTum has been completed.

Biovica, verksamt inom cancerdiagnostik, meddelade idag att bolaget avser att lämna in en FDA-ansökan om marknadsgodkännande för DiviTum i tredje kvartalet 2020 och inte som tidigare meddelat i … Biovica har avklarat den analytiska valideringen av DiviTum inför ansökan om godkännande hos amerikanska FDA. Nu återstår den kliniska valideringen innan FDA-ansökan under Q3. På sin kapitalmarknadsdag gick Biovica ut med nya mål för lanseringen av DiviTum. Man siktar nu på att nå en andel på 15% av total marknadspotential tre år efter Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA). "The 510(k) submission is a major step towards bringing DiviTum®TKa to patients and we look forward to working with the FDA to achieve clearance of DiviTum®TKa. Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration has resumed its review of Biovica’s 510-submission for DiviTum®TKa.
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Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that it is reallocating resources to COVID-19 impacting the timeline for completi Biovica.

Publicerad: 2020-08-26 (MFN) Biovica slutför klinisk validering med positivt resultat inför FDA-ansökan för DiviTum® TKa. Publicerad: 2020-08-26 (MFN) Biovica, verksamt inom cancerdiagnostik, meddelade idag att bolaget avser att lämna in en FDA-ansökan om marknadsgodkännande för DiviTum i tredje kvartalet 2020 och inte som tidigare meddelat i mitten av 2020. ”Vi gläds åt resultaten i den analytiska valideringen, Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has resumed its review of Biovica’s 510(k)-submission for DiviTum®TKa. “This is fantastic news on our journey to make the test available to US patients as early as possible. We see great value of the test in clinical practice, as BIOVICA.
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2020-09-25 · Biovica lämnar in FDA-ansökan om Divitum Biovica, verksamt inom blodbaserad cancerdiagnostik, har lämnat in en 510(k)-ansökan till amerikanska FDA för Divitum, enligt ett pressmeddelande. Nyhetsbyrån Direkt

Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510(k)-submission for DiviTum®TKa. The FDA currently estimates that the reallocation will last another 90 days, approximately, during which time the FDA will not be able to continue reviewing Biovica’s submission. Biovica, active in blood-based cancer diagnostics, today announced that the company’s 510(k) submission to the US Food and Drug Administration (FDA) for the blood test DiviTum®TKa will proceed to substantive review when the COVID-19 related pause ends. Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510 (k)-submission for DiviTum®TKa. Biovica, active in cancer diagnostics, today announced that the US Food and Drug Administration (FDA) has indicated that its previously communicated reallocation of resources to address COVID-19 continues to impact the timeline for completion of the review of Biovica’s 510 (k)-submission for DiviTum®TKa. Biovica, active in blood-based cancer diagnostics, today announced that the company has filed a 510(k) submission with the U.S. Food and Drug Administration (FDA). "The 510(k) submission is a major step towards bringing DiviTum ® TKa to patients and we look forward to working with the FDA to achieve clearance of DiviTum ® TKa. Biovica, active in cancer diagnostics, today announced that the company intends to submit an FDA application for market approval of DiviTum in the third quarter of 2020 and not as previously announced in mid-2020.

Biovica har sedan tidigare kommunicerat om en genomförd pre-submission till FDA där riskklass (II) och typ av process (510k pre market notification) definierades. Idag rapporterar bolaget att även nästa steg i processen, supplementary 1, är genomfört.

Biovica.

BIOVICA. 2021-01-29 20:29.