NorthWest Biotherapeutics Inc (NWBO)

[longusa]

Hey Austin, I understand where you are coming from. A couple comments.

First, the IMUC trial was 124 enrollees; they screened 278.

More significantly to your point, IMUC has not yet chosen a manufacturer for their product (they use 3rd parties, just like NW). So their manufacturing has not been FDA certified; when they finally choose where to do it, they will have to go through the same process Cognate has already completed on behalf of NW.

As well, Cognate has been transferring the technology to Fraunhofer over the past several years to bring up the German manufacturing capability, and has been shepherding Fraunhofer through the regulatory process with the PEI that resulted in certification there too. And the same has been occurring at King's College in the UK.

And Cognate has been the partner in developing -Direct manufacturing. Possibly having an already approved manufacturing for -L helped the FDA give approval for the broad Phase I/II for -Direct.

So, NW has been paying for much more than what IMUC has done so far. I don't know if is worth the additional expenditure vs what could have obtained from some other vendor. Given the perilous state of NW's balance sheet over much of the last several years, they may not have had much choice, and that probably played a role in more favorable terms than if they had robust cash at all times.

If the trials go well, NW having already set up approved manufacturing with Cognate in the US and Fraunhofer in Germnay will result in a much quicker TTM (time to money) after approval. We should see this play out in Germany over the next few quarters.