Replies to post #49495 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Wait, how can she out of the loop, but know about enough the efficacy to plan for...oh never mind :) Readyforbluesky

It's a good question, and one where I am almost completely stumped. However, remember that other drug companies/immunotherapy companies prepared manufacturing and in some cases guessed right, and in others guessed wrong. The point is the FDA is desperate, as is humanity, to find true significant breakthroughs, and close cooperation in an orphan designation might lead to appropriate prior planning, before interim results, that allow for manufacturing buildup until or unless told otherwise.

I'm still on the track that there are strict firewalls around LP and Les, at least since the resizing, and manufacturing preparation is intricately woven into a delicate balance between regulators, CROs, DMC, management and manufacturing.

You must pick up on certain language, and the language of Cognate is fairly telltale. They anticipated (back in July) that they would be done with building expansion about now, and 80 employees would be gradually added for post clinical commercialization.

We don't know they were talking about NWBO, but it seems to me they are trying to be ready as if this trial will be a success, but not get ahead of themselves more than necessary because nothing is guaranteed.

Now look at King's College, they are or have furiously worked out an initial 2 million pounds per year manufacturing agreement. Think about that, this is when enrollment is either sufficient or "very close" to complete.

Bears have given, and so has LP by the way, many examples where all this preparation simply leads to a nice new building for the next biotech to come along -- and unfortunately not for the ones who built it.

Again, manufacturing expansion could be explained by simple readiness as opposed to knowledge of good results.

The point is, due diligence isn't going to get me to what the data will eventually reveal, but the timing, particularly screening suspension and "active, not recruiting" are required by regulators and are the only likely current timing milestones that can't be fudged. But look again, Celldex thinks you can still enroll during a partial halt, but not recruit. So they read clinical trial's glossary different than what I do. All these human and biological variables turn biotech investing back into a science experiment.

Science and nature rule, even when man tinkers with it. So do your best, pick your companies and see if you're getting better at supporting the correct answers before they are determined.