NorthWest Biotherapeutics Inc (NWBO)

[Maverick0408]

Gary, CRL is not a mid to long term solution for manufacturing. You need to have your own manufacturing facilities. The risk you put yourself in relying on CDMOs once you start meaningful commercialization is immense. What if FDA finds issues with quality control during a routine audit? You are not in control of your destiny anymore. Plus CRL is not going to do this for cheap and hence NWBO’s margins will be squeezed.

That’s why all of the big pharmas including Kite (now Gilead) use their own manufacturing facilities.

I know so many companies in the med tech world that got shut down or paid hundreds of million or billions in fine because FDA found issues with quality control during their routine inspections. I live and breathe this world!

And keep in mind that manufacturing and distribution is not the end game. Although it’s the most time and resource consuming to set up, there are many other business functions a company will need to thrive. They don’t have any of that structure.

Make no mistake this company will remain a boutique operation and continue to limp along the next few years without a big pharma partner.