Replies to post #544880 on NorthWest Biotherapeutics Inc (NWBO)

[VikingInvest]

I am a former attorney, just not in patent law. I am not saying that paying the issue fee is an indication it works, I am just wondering if they would pay it before the compatibility studies were complete. If it was included in the MIA certification, it would make sense that they waited until the 'all clear' from MHRA before paying. I don't know if they could have made whatever changes to the flaskworks device and made changes to the patent application if the MHRA would have come back with some problems from their inspection. I don't even know if you can makes changes to the device after an issuing of the patent (which is the likely implication of payment) or if you have to file a new patent for the changed device.

[kabunushi]

It's clear to me that flaskworks will be a huge part of expanding the mfg capacity greatly and very cheaply and will be a part of the successful commercialization of DcVax as the new SOC for GBM. I don't however, know anything about what the formal process is for proving equivalence to the vaccines made by the current semi-automated process. I assume that will have to be a follow-on to the currently in-progress MIA.

[Doc logic]

QL300,

Comparability studies can be as simple as taking an initial sample of precursors from a donated leukopheresis and an initial tumor sample (any properly handled source) lysed and divided, then having monocytes matured and activated including with the lysate under the separate methods and then compared for end product DC purity and characteristics several times. Bottom line is the enclosed method always produces superior product and a slight change in the process, like needed for supply chain issues ie elimination of stoppers, does not change the maturation/activation process outcomes or the end product DC characteristics. You might say (ex)cessive concern has been (ex)pressed; ). Best wishes.