Brief: PCI Biotech Provides Update On Regulatory Interactions For RELEASE Trial

PCI Biotech Holding ASA

07/12/2021 17:52

Dec 7 (Reuters) - PCI Biotech Holding ASA  PCIB.OL :
    * UPDATE ON REGULATORY INTERACTIONS FOR RELEASE TRIAL
    * HAS CONCLUDED ON INTERACTIONS WITH REGULATORY AUTHORITIES
IN US
FOOD AND DRUG ADMINISTRATION, EUROPEAN MEDICINES AGENCYHELD
DURING 2H 2021
    * AUTHORITIES' MAIN CONCERN IS THAT PROPOSED MODIFICATION
WOULD
INTRODUCE A RISK FOR UNCONTROLLED BIAS
    * AUTHORITIES HAVE NOW REITERATED THEIR POSITION AND GIVEN
MORE
GRANULARITY ON THEIR CONCERNS
    * CONCLUDED NOT TO FURTHER PURSUE ADOPTION OF REAL-WORLD
DATA TO
SUPPLEMENT EXPERIMENTAL CONTROL ARM DATA IN A RANDOMISED FIRST
LINE SETTING
    * COMPANY CONTINUE WITH FULL FOCUS ON RELEASE ASSESSING ALL
OPPORTUNITIES TO ADDRESS RETENTION AND RECRUITMENT

Source text for Eikon:  ID:nGNE6NBdms 
Further company coverage:  PCIB.OL 

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