Replies to post #275293 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Personally I'd like to know how many are still alive, the status of the SAP, and I'd like to know if they have a target date for submitting a BLA for the trial, something that's not on your list.

I'm not a great believer in asking questions intended to embarrass management.

Gary

[manibiotech]

Looks good senti

[Sojourner55]

My top five : 6, 9, 1, 17, 18

[Dr Bala]

In my opinion, Question #8 encompasses Question #9. So, in my ranking, I am going to eliminate #9, although it is a very worthy question.

Thanks for all the hard work, Senti.

[H2R]

Hi Senti,

6 (include 11 in 6); 10.

Thanks so much for putting this together.

The way I see it, the timeline question (6) is the most relevant question. However, they may be vague answering that question. The dependency is the SAP status (11) and if they cannot answer the status of the SAP, they cannot answer any of (6). In other words, (11) should be the first part under (6).
They have hinted at 'close to final' on the SAP since June last year. They have to be able to say where they stand. If they can't, that would be a major red flag. We've also heard that once the SAP is complete, the other steps can follow in short order. None of the other steps have followed or have been hinted at yet.
^

The next most important question is the financing one, probably (10).

If we have a timeline and financing, I'll consider it a positive ASM. If we do not have a timeline, I will consider it quite negative.

Thanks again,

Best of luck to Patients, NWBO, and Longs!

[Dr Bala]

My vote for top 5: 6, 11, 3, 8, 1, in that order. My thanks to all that were involved in this effort.

[learningcurve2020]

#1 and 2 are good but bring your lawyers or she’ll run circles around you.

#8 is straightforward and add to it if any surviving trial patients went on to seek other treatments? And, if so how would you know?

Keep the questions to the trial, IMO. Assume it failed years ago and make them prove to you it did not. Push for documentation from the steering committee. Inquire about the CRO activities. Ask if any patients are shareholders. I’m sure you guys can come up with smart questions because nothing else matters if the trial is in limbo.

Personally, I’d ask if Black ever submitted a report on P5 and if so why was it kept from shareholders? And, if not what does he have to offer? Maybe it’s irrelevant maybe it’s not.

[NorthShoreTrading]

Is Sh meeting still on for April 18th? No way it's in person, did it swith to just a webcast?
Maybe I missed the update??

[iwasadiver]

As far as question #2 goes:

I believe this is already known as far as ownership of equipment. NWBO owns everything, including the lease. They are akin to the Prime Contractor in the ship repair business, among others (or General Contractor in the building business). Advent is the subcontractor in that they are simply a management company for the scientists/technicians who are performing the actual work of manufacturing. They have specialists who have been involved with the manufacture of DCVax and understand it completely. NWBO subcontracts this work as the Prime Contractor so they do not have to deal with all the management, the payroll, payroll taxes, insurance, hiring, etc. I’m not sure why this is an issue to be frank.

As a subcontractor in the ship repair business my specialty was the work. We figured out how to increase efficiency, manage the process, develop new ways of doing our part to add value. The Prime Contractor owned (or leased) the dry docks, the cranes, and the physical plant. They provided the raw materials, sand blasted the steel and provided a primer coat, provided the welding machine bank, the oxygen/acetylene tanks, the cranes, etc. They had a small crew for these things. I had 100 men working for me and supplied the welding rods, the physical torches and hose, the wiring to connect the welding electrodes to the welding machine bank, and any other consumable materials needed to accomplish our work. The Prime Contractor paid us a fee based on weight, i.e. $4/pound of steel replaced. If we did 60 tons of replaced steel we got paid $480,000. We were not some subsidiary or any other entity. We were subcontractors. If I brought a project to the shipyard in the form of a contract we got the work and we got a commission on the sale of the job. It was in our best interest to bring the work to the place we knew, and the place we understood the facility and what the physical plant’s capabilities were. I think the arrangement with Advent is very similar so I’m not sure what the controversy is; this appears like typical Prime-Sub contractor stuff to me.

[Hbpainter]

Thanks senti, Ike and everyone for the questions.

1,3,6,11,17

[ahp123]

Thanks sentiment_stocks, great work :-)
Bw

[dude409]

senti, thanks for all of your efforts on this project and also those who made suggestions.
My vote: 1, 6, 17, 3, 11

Thanks to the entire medical community in their super efforts to take care of mankind in this worldwide emergency.

[antihama]

1) 11. (H2R)
What is the status of the SAP?

2) 17. (Sojourner55)
Did you extend the trial so long due to the 17 less control patients and/or crossover confoundment? Are you waiting for a certain number of events to be more assured of a separation between your control and treatment arms?

3) 9. (hankmanhub)
HOW MANY ARE STILL ALIVE TODAY?
Note - This is essentially the same Q as Reg's Q8 w the difference being Q9 asks for TODAY vs Q8 asks for such and such a date. I can see them them easily sidestepping the date by giving old news. PS I doubt they'll answer it anyway.

4) 2. (Exwannabe)
Could you describe the relationship with Advent at the Sawston facility? I.E., who owns the equipment, Northwest or Advent? Could you explain in some detail how Advent will pay for the use of Sawston? Will NWBO have to pay Advent to reserve capacity for the production of DCVax, and if so, why? Is Advent free to use the facility to make product for other customers as they wish?

5) 6. (Senti, aph 123, Pablosrv)
When will data lock take place, and how long after that can we expect top line to follow? We have heard that it could between two weeks to two months after data lock before we could receive top line data. What are the reasons it could take up to two months?

PS - I'm still of the mind that TL will be days to 2 weeks after Data Lock but whatever the answer is I'll be happy if they answer it.

Thanks Senti for putting this together and Ike for communicating w management on it. There's a lot of other Qs here that are good but there are a couple of layups and sidesteps too prolly including the ones I chose but here's hoping.

[kabunushi]

3, 6, 7, 8, 10

Thanks for your work on this!

[photonic5]

Is there room to add one more? Is the company purposefully delaying unblinding of the P3 trial due to disagreements with regulators over endpoints and trial analysis? If so, how long is the company willing to wait on datalock and unblinding if no agreement can be achieved? Indefinitely?

[sukus]

11, 9, 6, 3, 20. Thanks Senti.

[manibiotech]

(1 &2 should be one question)
6
9
11
18

[Sojourner55]

I'm revising my vote to include Photonic's question as my top 5:

6, 9, 20, 17, 18

Many thanks for all this work Senti and IkeEsq.

[reg2015]

My choices>>> 4,9,11,15,20. T U Peace Reg 2015

[sharpie510]

9 6 3 11 20

Thanks Senti.

[Looking4aprofit]

3,6,8,10 &11
Thanks

[Stinkysweet]

These are all great questions but do we really think that they will have a Q&A? I think they will talk at us and control once again the whole narrative.

[eagle8]

9, 10, 11, 16 and 17.

Thank you.

GLTU

[richdag]

Please add this question to the list to be voted on: "Have you had any discussions with other parties regarding either partnership or buyout? If so, what can you tell us about that?"

[BlueJordan]

Q's 6,1,17,3,4 bag my vote Senti.

Thanks again, for putting all of this together. I wish you/us luck in getting the management to answer transparently( and deliver).

[Bigmahalo]

Still lurking, reading daily.
All of you regular posters are amazing and appreciated.

6,11,9,1

[sukus]

Please cancel my previous vote. Thanks Senti.
I favor this one:
11, 9, 6, 20, 21

[CaptainObvious]

15 60 75
Oh wait. That's The Numbers Band

I'll say
3,6,9,11,17

[791branko]

1, 3, 4, 6, & 15

[Tandanako]

3,6,9,10,21

[Pharmboy46]

1, 3, 6, 9 and 11 please and thank you for all that you do! Goes for all posters but especially Senti and Ike for compiling the questions!

[inveterate]

6,9,11,17 and 21
Thank you for all the work you have put in.

[Doc logic]

1,3,8,13 and 15. Been absent for a while. Thanks and best wishes.

[vator]

I see there isn’t a question about Direct. We were promised a pediatric test about a year ago.

Do not know how I would frame it but we have been promised testing in areas and they just evaporate. Can you elaborate on each one you promised publicly and what is the status and why?

[pgsd]

1, 3, 5, 6 and 11

Many thanks Senti and for everybody who contributed.

[john1045]

Thanks Senti and Ike for taking your time to pull these questions and tabulating the voting of top 5 questions for NWBO management to try and answer for the ASM.

Here are my top 5: 6,3,9,15,18

Thank you!

[photonic5]

3,6,11,16, 20

[IkeEsq]

About 3 more hours to get your votes in.

Ike

[CherryTree1]

I know I am late submitting this, but after reading these seems like we are missing or light on questions concerning Dr. Duffy's sudden departure from NWBO leaving to go back to work for Merck.

I Suggest this question:
The company recruited Kevin Duffy, Ph.D. on the strength of his experience working in cancer immunotherapy and his experience dealing with the regulatory agencies. Was his departure unexpected or was it more that he has successfully completed the work NWBO wanted him to complete and returned to Merck as had been planned from the start? Why shouldn't shareholders view silence about the reasons for his sudden departure as a sign that after getting a closer look from within NWBO at what was going on with DCVAX-L that he concluded the trial is destined to fail, panicked about his poor choice of career moves and begged Merck to give him his old position back?

[alphapuppy]

3,6,11,16, 20

[NeWBrO]

15 , 17 , 8 & 2 have been on top of my list of questions . Thank you all for your support of both stockholders and assisting the company manage & navigate through these difficult times ...

[ahp123]

1, 3, 6, 10, 11

[Whitewater55]

6, 10, 11, 18

Thanks Ike. Several of the other questions I had already provided DI’s response via a previous phone call.

[Whitewater55]

Innes response to 4. (IkeEsq) What if any impact is Covid-19 having on this process or NWBO in general?

Paraphrased... “it really doesn’t affect the process or NWBO in general. Most of our work is done virtually and each of management works remotely (proceeded to name off locations were Linda, Les, himself, Duffy, Marnix live highlighting that “stay-in-place” orders doesn’t change the way they do their jobs). Sure, there is potential that the FDA may slow down a little but that is out of their hands.

[FloatServe]

1,3,6,8,19

[Whitewater55]

Innes response to question 3...

Paraphrasing... “they will start to generate revenue by the end of the calendar year if they can get Sawston up and producing DCVAX-L. They will point to the revenue coming from humanitarian use in the UK. Anticipate 30-40 users a month if vaccine is available. Currently, coronavirus is throwing it for a loop. (Neglected to reference this comment about COVID-19)

[sentiment_stocks]

1, 2, 3, 6, 9 - Time to get in my vote. :)

[Whitewater55]

Innes response to question 6:

These milestones all have timeline ranges to them and we’ve done what we can to be ready. However, we can’t always control the timelines. We are waiting for data lock, unblinding, then top line. We plan to immediately communicate information when necessary.

[JTORENCE]

Numbers 6, 8 and 9 should be renumbered as 1, 2 and 3. Their response (if favorable) will propel the share price in an upward direction. The market wants this info, the rest at this point is all window dressing.imo

[veeets]

6, 9, 11, 20, 21. Thanks.

[Lykiri]

3 6 9 13 15

[IkeEsq]

Voting Results

Top questions:

6 (32)
11 (23)
3 (22)
9 (20)
1 (13)
17 (11)
20 (9)
21 (8)
8 (7)
10 (7)

There were a bunch of votes that were not replies to the original message and some changed votes, so I just went through every post since the list of questions. My tallies are below, feel free to make sure your votes were counted. I did not add votes for people who submitted questions but did not vote but it would not have changed which questions made the top 10. Also, Hbpainter voted for five questions and then added a sixth but that also did not affect which questions made the Top 10.

Absent any material miscounts, I will submit the top 10 to NWBO tonight (in about 5.5 hours).

List of Votes

[Evaluate]

Here is my vote for the following 5 questions:

2, 3, 4, 6, 8.