Independent

[flipper44]

TheFollower has a post on ihub NWBO that projects averages if MHRA conducted a discretionary review with CHM July 25 prior to any final MHRA decision, and, if thereafter approved by MHRA, an announcement could occur between August 2 and August 10. If so, I’d think a decision in that window, that early, assuming we’ve gone through 3 RFIs, would only occur due to motivation to match any approximate mhra accelerated150 day clock on plus (NWBO required no more than 365 day clock off schedule). I don’t know if 150 days is compelling to MHRA and/or NWBO or not, but at minimum, August 3 starts the latest possible normal sixty day, window for an innovative medicine MHRA decision whose day 0 was March 6, 2024, (if there were three RFIs) give or take a few days, of:

1. 150 clock on + 365 days clock off = August 3 (give or take a few days)

Or through possibly as late as

2. 210 days on + 365 days clock off = October 2 (give or take a few days)