Replies to post #559056 on NorthWest Biotherapeutics Inc (NWBO)

[hoffmann6383]

Over budget and behind schedule would get most people fired from their job. Flashworks might be great at the end of the day, but there’s really no excuse for the current state of play.

Nonsense. No one has developed such a system to do what NWBO is trying to do. This is for personalized vaccines. To develop, test and then get RA approval isn't an easy process. It takes time to innovate.

[lutherBlissett]

Elon Musk would have had Flashworks fully operational within three months.

oh yeah Mr. Quality Control himself. just a note that no one gets extra credit for worshipping rich people.

[Whitewater55]

Elon Musk would have also devalued the company by half in a matter of a few days.

[dmb2]

I am not going to disagree with what you say from a timing standpoint. i will only say that startups take longer to develop and even then RA's will question further and rightfully so. I just know the development cycle for technology and products.
I have come to understand and accept the wait for 5 yr OS data but since that time I still wrestle with their timeline as I think all development should have been done concurrently within the wait. I keep working to comprehend what they are doing now and believe they are wrapping up their MAA/BLA for submission in this quarter (I hope). I would like to believe they have been doing a rolling submission but I am not so sure about that. I know how voluminous such submissions are and I know how BP's build them over concurrent time and hope NWBO has it about done.

GLTA

[dmb2]

PM, one additional thought. I have hoped for quite some time they would partner with a BP. I know hindsight is 20/20 but when you look at their valuation and their number of shares outstanding and then consider a BP partnership back in 2015 along with greatly expanded resources that may have been the better path. This assumes there was a good BP to partner with though I am not sure of that. So, though LP has navigated through extremely difficult waters of all types I will have to speak to her some day to understand their earlier decisions to know whether her time at the helm was really insightfully heroic or just herioc to save the day she created.

GLTA, DCVax is now close

[hyder]

Hi PM, your use of Flashworks for Flaskworks is intentional I believe. It's funny if it is intended.

[biosectinvestor]

There is absolutely no indication that anything you just posted there is vaguely true. It is cutting edge, no doubt, and scaling it may involve efforts behind the scenes, but no one here knows exactly how far along they are or what it involves and there may in fact be no real delay at all, just a need to get the approval process going based on mostly, not all, but mostly current production tech. And slotting in Flaskworks, while it may be Sawston 2.0x that may not be that far out, and the validation may be much further along than anyone thinks, just not part of the current rollout. No one knows. And their job is not to tell everyone every competitive detail at every moment. If they have a supply issue, that is to be addressed as well, and there is no guarantee that a larger company would have a faster or better solution there either.

Anyone can throw up uninformed opinions. The secret is to know when one’s opinion is opinion only and probably more guess than not.

[dennisdave]

What makes you think Flaskworks is the bottleneck in the process toward MIA?
Manual production can be certified and MIA granted upon it. I cant imagine NWBO being so stupid to promise MHRA/NICE Flaskworks and thus all agreeing on Flaskworks being the prerequisite for MIA?

Whatever is holding up MIA cant be technology still in development, Flaskworks or not, otherwise they would not have filed an application for a license of manufacturing facility on July 6, 2022. That would have been the same as filing a request for an Authorization to Release Certificate for a new technology highly developed plane with the FAA while having half the jet engine still hanging in the ropes and the other half on blue paper. I just cant believe they would be that stupid.

I am convinced its minor issues before MIA can be granted.