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Saturday, 08/19/2017 4:23:05 PM

Saturday, August 19, 2017 4:23:05 PM

Post# of 720881
From NWBIO 10-K:

"Cognate BioServices’ manufacturing facility for clinical-grade cell products is located in Memphis, Tennessee. Cognate BioServices' facility is approximately 80,000 square feet and contains substantial buildout expansion space in addition to the portions currently built out and in use. The current manufacturing facilities ARE SUFFICIENT to produce DCVax for at least several thousand patients per year. The expansion space will allow us to procure significantly increasing capacity when needed for commercial readiness.

We are also developing a facility for manufacturing in the U.K. for the European market. It is necessary for us to have manufacturing operations in Europe to meet the logistical requirements for European patients relating to the collection, delivery and processing of the patient’s blood draw containing the immune cells (for which the time window is too limited to reach the US manufacturing facility)."



I might be wrong, but this might explain some things regarding new NICE timeline. Just guessing though.

In other words, "Developing" versus "Are Sufficient".


Because NICE must consider Manufacturing readiness:

"NICE then invites consultee and commentator organisations to take part in the appraisal. A consultee organisation would include patient groups, organisations representing health care professionals and the manufacturers of the product undergoing appraisal. Consultees submit evidence during the appraisal and comment on the appraisal documents."

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