Replies to post #544782 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

We agree :)

[skitahoe]

I believe right now your item 1 is the key, approval of the manufacturing facility. No one has come out clearly and said that Sawston is, or isn't, attempting to gain approval with the FlaskWorks units incorporated. If in fact they're approving manufacturing with FlaskWorks it would be huge, I believe the other regulators would follow quickly behind once NWBO has regional facilities established.

On the other hand, if the company is still in the process of qualifying the FlaskWorks unit with all four regulators I don't believe an attempt will be made at approvals elsewhere utilizing only manually operated clean rooms for each batch of the vaccine being made. Hopefully the status of this effort is cleared up at or before the Annual Meeting, the time to approval can't be estimated until we know they have approval to utilize the FlaskWorks units.

Gary

[MasterKit]

Once again, if they are using the EAMS pathway (which I highly suspect they are), the discussions around reimbursement and pricing may have already been had, or at least, will be had once submitted within the scheme.

https://www.nice.org.uk/about/what-we-do/life-sciences/office-for-market-access/early-access-to-medicines-scheme

[flipper44]

There is an interim form of MHRA funding available to some therapies that will otherwise take much longer to go through the regular NICE pathway. It is faster, has a lower burden of proof initially, and it’s meant for serious diseases. (It’s often used for Orbis Oncology therapies)

Please see post 417483
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=166765554