Lukter litt sånn NANO rally på dette…
Både kursmessig gruset og fall før Q og ser ut som de fleste kastet korta i PCIB når en leser kommentarer her.
Gledelig blir selvsagt at den desidert mest verdifulle asset i avsluttende fase opplever økt screening. Det er vanskelig å diskutere på dette (spesielt når en vet at tilnærmet all verdi i analyser er tillagt RELEASE).
We are seeing increased screening and enrolment into the study«
«… . The study protocol was thereafter amended, and an optimised protocol implemented during the autumn 2020. The expansion to include new countries and sites have run in parallel and the RELEASE study now spans across 47 sites. The expansion to Asia has shown initial good screening and enrolment. The study communication has also been strengthened, both by the establishment of several online tools, interaction with patient organisations and publication of case reports. We expect to see the full effect of these efforts when the Covid-19 vaccination starts to reduce the effect of the pandemic on the healthcare systems.»
► Open sites in South Korea, Taiwan, USA and 11 European
countries
► Ukraine has been added to the country mix, replacing UK due to approval delays and trial competition
…early indications after implementation of the amended protocol are encouraging with increased screening and enrolment. The opening of sites in Asia has also shown promise as the first patient was enrolled in South Korea in October, less than three months after opening of the first Asian site. The situation has been difficult in the US, but the new amendment has now been implemented at all sites. First patient enrolled in the US is expected 1H 2021.»
Bonusfrelst dette er som alltid:
«The planned communication milestones for the pivotal RELEASE study will be quarterly updates on the number of countries and clinical sites open for recruitment, as well as updates on expected timelines for major milestones. Other milestones and updates will be communicated as appropriate, including outcome of the IDMC reviews, as well as further details regarding timing and plan for interim analysis»