NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

Gary,

They had 30 months to get CRL contract and manufacturing in place. As to some of the advance payment to CRL and/or the requirement of Flaskworks, that’s one of the worst excuses. First, Flaskworks is not required by FDA or any other regulatory approvals. Second, you don’t wait months and years for Flaskworks production to come online and delay the application. Instead you start generating revenue by getting approvals ASAP using manual production and gradually transition to semi or fully automated manufacturing by reinvesting some of that profit back in R&D. Third, if management was truly committed they wouldn’t have offered themselves true up and instead used those million of shares to invest in bringing CRL online when the share price was around $1.5 or so on so many occasions over the last 30 odd months. Or worst case, they could have requested additional authorized shares soon after data lock when share price was over $2 to fund some of the upfront CRL manufacturing costs.

I continue to believe they are waiting on ph 2 combo trial results to come out before applying to FDA. Perhaps MHRA is willing to approve based on ph 3 data alone, but FDA may have indicated they need to see more! Otherwise, I can’t think of any other reason to continue to delay FDA application for over 2 years when it gives you access to the most lucrative and biggest oncology market (around 50%) as opposed to waiting over 30 months to apply for U.K. (due to Sawston certification) which is only 5% of the global oncology revenue.