Independent

[flipper44]

After reading a more accurate outline of innovative medicine maa timeline aspirations. See here: https://www.pharmavibes.co.uk/2025/05/22/__trashed-3/

I guess it could have gone more like this, assuming 3 RFIs.

March 6, 2024 clock on.

1. MHRA exceeded 90 days and likely took more like 120 days for first assessment clock on. (120 calendar days accumulated)
A. NWBO used full 6 months clock off to respond to first RFI. (300 calendar days accumulated)
2. MHRA knew it was behind, so only took 30 days clock on of normal 60 days for second assessment. (330 calendar days accumulated)
B. NWBO, according to guidance, supposed to hurry here and try not to take full 3 months clock off allowed. Let’s hypothesize they used two months to respond. (390 calendar days accumulated)
3. MHRA knew it messed up early on tries to keep its third assessment shorter at, let’s say 20 days clock on to issue third RFI. (Accumulating 170 days clock on thus far) (410 calendar days accumulated)
C. Not wanting to screw up third RFI, NWBO takes full 90 days to respond. 500 calendar days accumulated.
4. MHRA still trying to make amends, hurries and although it could take 40 days and still meet 210 days, it tries to take less. In other words, decision could be between now (514 days) and a a bit over a month from now — around September 9.

Still, the reality is, the maximum would be first week of October, imo, and NWBO seems to find ways through happenstance or something else, to take the maximum time.