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Børs og finans

Siste nytt fra PCI Biotech

PCI Biotech oppdaterer markedet.

Administrerende direktør Per Walday i PCI Biotech Holding ASA. Foto: Finansavisen

Per Walday
Adm.direktør

Administrerende direktør Per Walday i PCI Biotech Holding ASA. Foto: Finansavisen Per Walday Adm.direktør

Artikkel av: Marianne Løland Skarsgård
20. desember 2017 - 08.46
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PCI Biotech har ifølge en melding nådd en felles forståelse med European Medicines Agency (EMA) og U.S. Food and Drug Administration (FDA) rundt de regulatoriske omstendighetene knyttet til utviklingen av produktet fimaporfin.

De viktigste faktorene som det enes om er tilstrekkeligheten av en enkel randomisert todelt studie, samt potensialet for akselerert/betinget godkjenning basert på foreløpige resultater.

Videre opplyses det at implikasjoner av en foreløpig analyse for det endelige sentrale studiedesignet vil kreve videre diskusjoner med myndighetsorganene.

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Something is broken. Please let us know what you were doing when this error occurred. We will fix it as soon as possible. Sorry for any inconvenience caused.
An Error Occurred: Forbidden

Oops! An Error Occurred

The server returned a "403 Forbidden".

Something is broken. Please let us know what you were doing when this error occurred. We will fix it as soon as possible. Sorry for any inconvenience caused.