Replies to post #66068 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

"So, if I can ask a question to make sure I understand: Does a company need proof of large scale commercial manufacturing ability before FDA will give their approval? I thought they had time after approval to get their manufacturing in order." -- Beartrap

"For an investigation to be considered adequate for approval of a new-drug, it is required that the test drug be standardized as to identity, strength, quality, purity, and dosage form to give significance to the results of the investigation."-- Sec. 314.126 Adequate and well-controlled studies.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=314.126

Before any batch from the process is commercially distributed for use by consumers, a manufacturer should have gained a high degree of assurance in the performance of the manufacturing process such that it will consistently produce APIs and drug products meeting those attributes relating to identity, strength, quality, purity, and potency. The assurance should be obtained from objective information and data from laboratory-, pilot-, and/or commercial- scale studies. Information and data should demonstrate that the commercial manufacturing process is capable of consistently producing acceptable quality products within commercial manufacturing conditions. -- FDA Guidance for Industry, Process Validation-www.fda.gov/downloads/Drugs/.../Guidances/UCM070336.pdf

[kabunushi]

It's a key strategic decision and we are in a unique position in the totally individualized treatment area. Argos has a similar therapy. They originally (as of end of last year, until this spring) had a plan of record to build automated mfg now as they head toward end of their ph 3 trial in 1H 2017. But when they raised $60M they needed for their plan as announced in March, they said they were putting off the automation to preserve cash and the laid off about a dozen staff who were working on it.

They said they only anticipate treating 600 patients in year 1 and not that many more in year 2. It makes sense that LP & NWBO are more aggressive and see a lot more demand for GBM and with combination trial for other cancers, and Vax-direct, it seems reasonable that they took a more aggressive direction even while stretching to finance it. Obviously they didn't anticipate how quickly the stock would fall with sector-wide weakness. A huge mistake in retrospect and in general seems really stupid not to have gone for a financial margin of safety, but they were obviously blindsided by the NW public arguing fiasco. Anyway water under the bridge, this is where we are and it makes a lot of sense to get mfg ready if you can while in the last year-1.5 year of the phase 3 trial. But it also heavily pushes the risk by spending a ton of $ before you get approved. Argos backed away from that but in doing so majorly punked out on the max number of patients they can treat in the first 2 years after approval if they get it.