NorthWest Biotherapeutics Inc (NWBO)

[manibiotech]

From my previous post:

From UK.gov/MHRA website
"If necessary, we will send you a third to resolve any final minor outstanding issues and switch off the clock. There are no fixed submission dates for your responses to the third . You must submit your complete response to the third within 3 months. If you do not submit a complete response within 3 months, we will notify you that we propose to refuse your application. We will restart the clock within 3 days of receiving your complete response to the third as an sequence as described in section 2.4. Once all outstanding issues are resolved, we will conduct final compliance checks and grant your application by Day 210."


In my opinion two most likely scenarios are :
- above excerpt from MHRA website. So they may have received a third RFI sometime this year and had 3 months to respond during which time clock stops again . We don’t know where we are.

- Referred to CHM . Again clock stops I believe

Now looking at repeated statements by MHRA that back log has been cleared , these seem to be most logical scenarios to me.
Waiting for new laws/regulations to be ratified , waiting for comment period to end , waiting for Flasworks , tumor agnostic etc don’t stop the clock as I at least can’t find these to be valid reasons for clock of periods on MHRA website . Folks who keep pushing these reasons may want to post some link from MHRA guidance stating these to be valid reasons for clock off period.