Replies to post #584011 on NorthWest Biotherapeutics Inc (NWBO)

[CaptainObvious]

I continue to believe they are waiting on ph 2 combo trial results to come out before applying to FDA

I think something along those lines is "possible", but not likely. If there is an MAA granted, they won't need it, but can point to the results of the combo trial, that are known so far.

[hoffmann6383]

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

I recommend reading the DNDN story. FYI - NWBO has a former DNDN executive on their board. One of DNDN 's biggest mistakes was getting manufacturing ready well before it was needed. This led to their bankruptcy. Your suggestion could lead to the same fatal outcome as DNDN. NWBO learned from those mistakes and are trying to time supply with demand. I'll close with this - I'm glad we have the leadership we do.

I didn't read the rest of the post. I couldn't make it past the part of wanting to put NWBO on the same path as the bankrupt DNDN.

have a good one friend!

[Poor Man -]

These are all good points, Mav,

I know they’ve always had concerns and issues with FDA, and that’s why they focused their efforts in the U.K. Whether they still have issues with FDA at this exact point in time is an unknown, but is a legitimate concern by investors — especially with no guidance from Linda and Les.

As far as the true up goes, the only positive to take from this is they desperately want those additional options awarded to themselves, just based on how outwardly aggressive they became in promoting a defense against the true-up lawsuit.

The urgency and size of the “bonus” speaks to an expectation they’ll realize value on those options. Perhaps in the immediate future. So reading the tea leaves, they likely have something in place that will improve the stock price. Whether that’s a listing and/or something else is TBD.

[dennisdave]

I continue to believe they are waiting on ph 2 combo trial results to come out before applying to FDA

If the FDA is not prepared to approve DCVAXL based on the data from the P3 trial, then that would mean the trial is a bust which is a material event and would have been disclosed by NWBO long ago. Therefore it's nonsense.

[skitahoe]

Maverick,

While all you say is true, I believe the cost of building perhaps 50 to 100 tiny cleanrooms to meet minimum FDA demands could go well into double digit millions, if not triple digit. I think they're going to use CRL for production and certainly have discussed what they're intending to do, but I believe they're committed to FlaskWorks Eden unit as long as they continue to believe that it can deliver the vaccine. I suspect the Memphis facility will accommodate sufficient Eden units to meet U.S. demands for the immediate future and they're accepting the delay in the time it will take to get there. This is JMHO, but I also believe that if they started today to build say 100 individual cleanrooms that effort could easily take a year or more as well. Certainly if a couple years ago they determined they'd build the cleanrooms, they could be ready today, but unless they either took on a massive funding effort, or partnered with CRL at a time when stock was selling at bargain basement prices, it wouldn't have been in the best interest of shareholders as long as they believed that Eden could be on line in a reasonable amount of time.

Let's get the U.K. and perhaps other approvals based on what they've done at Sawston, that should dramatically change the share price and put them in a much better financial and bargaining position, at that point they can again access the Eden situation and if they don't believe it's close to being ready for certification by the regulators, then they may commit to building all those cleanrooms deemed necessary for FDA approval.

Of course I could be completely wrong, perhaps the FDA will accept the limited production available at Sawston for meeting everyone's initial demands. All four regulators could jointly approve the vaccine and allow demand to bring additional production on line. CRL may also have some existing cleanrooms they can devote to production and add to the capability at Sawston. If this is the case, NWBO could be in the process of submitting to all four regulators simultaneously, the U.K. is the only one that had the inspection of the production facility before the submission for approval, all the others have it as part of the submission for approval. The company has made it sound like they intended to apply to more than one regulator, so this is certainly a possibility.

Much really depends on how FlaskWorks is doing with optimizing the Eden unit. To the best of my knowledge the last we heard about that is the Annual Meeting, over 3 months ago. If by now the company believes the unit is ready to undergo examination by the regulators, it's approval may not be that distant. On the other hand if they still feel it's months away, no telling how long it may take. Perhaps we'll get an update at the upcoming NYAS conference. I previously asked the capabilities at Boston, I.E. do they have the capability to make, and certify the vaccine there, or will the Eden unit be tested for approval elsewhere, no one seemed to know for certain. I would think that if FlaskWorks Boston is optimizing the Eden unit there, they would be able to make the vaccine there, but I don't know that to be a fact. I have no idea if FlaskWorks in optimizing the unit is modifying it in any way, or purely tweaking the way it's programmed to operate, so the change is only in the computer controls. If it's purely a computer issue, I suppose it doesn't really matter where the units are located, they can do the program change, make new vaccine and observe the results and make comparisons to vaccine made manually from the same patient. I would guess that this is being done from both new patients being added under compassionate use and material from patients in the trial who've already evented.

Gary

[biosectinvestor]

You are so wrong on these points and I do not have time to go through them with you, but unbelievably so.

1) cognate requires millions of dollars to get ready to manufacture and dedicate lines to DCVax-L production, up from typically;

2) they have production capacity already at Sawston;

3) getting Flaskworks ready does not detract from getting ready but spending millions of dollars up front before you have applied is exactly what sunk Dendreon;

4) the FDA requires none of what you said and they actually already have an option contract in place with cognate to negotiate for production upon approval, they do not necessarily need more, given Sawston;

5) why would they waste precious corporate assets at this time, giving massive amounts of money to a third-party if they do not have to do so, especially when possibly in a few months or weeks Flaskworks machines can come online and all of those resources and funds will have been wasted?

6) you do not even know what the state of their negotiations are with Cognate and they do not necessarily need to make every possibility public at this time. There are ways to effectively contract with a third party with more detail than they even have now, to reassure the regulator that they have capacity to expand production on demand, when and where it is potentially needed without exercising a contract that needs to immediately be published or released and can be on a quiet contingent basis triggered not just by things that have still not yet occurred. The contingencies can be considered far off and not yet material for purposes of disclosure but adequate for a regulator to bad an approval upon.

The fact is, no one commenting here is “the expert” at what they should be doing and haven’t done yet. No one here is even vaguely in the know. I am not in the know. I do know how these kinds of projects can proceed however, how project financing works and how companies can have a lot of balls in the air at once that each and all fall into place at an exact moment in time that even many insiders themselves may not understand the full details. But more importantly, what can be done broadly and within the bounds of contracts, legal obligations and regulatory requirements is so broad that presuming one knows things one does not know, from a bulletin board, is pure vanity and silliness.