Vator, guess it depends on the time frame if management has created and maintained value. In my nearly 8 years in the stock imo they have not created much value. I think there is still potential to create value but I am waiting on that series of PRs to start and improve the valuation. I think the company could give and update to the 25 on the information arm and the group of 32 pseudoprogressors and bring more attention to the solid results.
The Dr Liau presentation and q&a was excellent, too bad it got taken down I wanted to watch a second time and show others.
Let's see those PRs!

Sure hope we get something before asm and data analysis was complete September 2021 so did have lots of time to potentially share results with possible partners

Ex is correct as is your support of him on the loan - at least so it appears from the”q”.
Appears to be due for a small stock sale this month or next

Ex, don’t know if she has issued more shares yet but price action and volume sure seem to indicate another stock sale is near - and once again at a discount. Some vehemently disagree but I also believe they are just raising a month or two of cash at a time, but I did not expect next sale until end of month

I would be much happier if Flipper’s prediction of before July 4th had been correct but it seems that probably didn’t happen
Clearly I’m not the only one thinking November for the 4 year time since last patient started on DCVax, see meirluc’s thoughts Even if he does not now think that to be the reason and am now understanding that ex had similar thoughts
The question was put out for a guess as to when sap completed and accepted so my guess is November for the reason I stated. Sent I believe guessed September to November (I think)
So what is your guess on month for completed and accepted sap - by all 4 regulatory agencies and your logic for the date?

What I am unsure of is how long after sap is all good will it be to release of top line. I believe it was exwannabe that quoted a statement by Powers that even that could be a lengthy process. I also remember that quote by can’t seem to find it

I will take a guess and say November. Perhaps nwbo wants a full 4 years of data since last patient started DCVax. If they are indeed having back and forth discussions with fda I hope when they submit it can go smoothly. Then a final data collection, query resolution and start the analysis. Could this long time to write the sap just be a way to get to 4 years of treatment data on all 331?
Just a wild thought....

Iclight I did contact another immunotherapy company in a phase 3 (near the end of p3) and asked about their sap and Ir had a difficult time even understanding my question as of course they already have one in place waiting on the os data. Theirs is much simpler with no crossover but have had it in place for some time now
I hope that iwasadiver’s explanation holds true in that nwbo’s is far more complex and incorporating new knowledge but does seem like a long time

Dr Bala, happy? Not yet but I will be when the company has a series of announcements
1 we have submitted the draft sap to all 4 agencies
2 all regulatory agencies agree this is a reasonable sap
3 the unblinded data is now in the hands of our statistical consultants and we expect their conclusions by x date
4 release of top line data with detailed analysis to be shared at y conference

In meantime I expect next announcement to be the quarterly report is delayed, followed a few days later with the quarterly report
Then if the start of 1 to 4 above not initiated, a small stock sale to buy time to get to 1 through 4

They were trying for many months to get the paper published in a higher level journal. Bosch or Powers spoke of it at some presentation and how it could take many months to be accepted. Goldman spoke of how it takes time on multiple calls with me. In end they went to JTM and got it published very quickly and never again spoke of how they tried to get in a higher level journal. After being published I spoke of it once with Goldman and he did not really want to discuss and I said just happy it finally got out there in any journal

So yes, they did try but took what they could get

That’s it thanks Lykiri!

Does anyone remember the interview of Dr. Liau in which she stated that her greatest professional achievement was developing the DC vax vaccine for gbm? I can’t find the link anymore
Thanks

Iwasadiver, I know you are an ER doc and not in research, but do you have an idea on how long it should take to develop a statistical plan?

I like Lowe’s too, they have some things can’t find at Home Depot

Kab, check my post #238061 and to add to it look at the balance sheet cash position for the last several quarterly reports. As of September 30 2019 cash of $248k - almost nothing. After Sawston sale on balance sheet dec 31 2018 $22.2 mil cash. On March 31 2019 cash of$16.3 mil. Now also look at the current liabilities on only the accounts payable (A/P) line as the rest of current liabilities are very large. Just the AP line for March 31 2019 is $15.3 mil. So just think if someone wants to actually get paid for their services what is on the A/P of $15.3 mil and have $16.3 mil cash that leaves very little. This ignores all the other current liabilities that on the March 31 2019 balance sheet total $74.2 mil (combined including A/P) - just accounts payable (get it)

Now add to that on July 16 nwbo raised 2.7 mil why raise if have plenty of $? Also go to the ASM on February 2 2019 question #3 answered by Powers. I think all she spoke of could take some $, actually lots of $.

So yes I expect another stock sale probably late August to early September as don’t want to get down to balance sheet cash similar to sept 2019 or even June 2019 - June was not good either

Now do you still maintain that I’m “throwing out BS” ? Let’s see your version of how you see it and your dd.

I’m long but not blind to how in my opinion this company acts very odd as compared to my many other holdings

We have all sorts here, pure bashers, pure cheerleaders, some incredibly knowledgeable ones, and an occasional realist, think I know which I am

As said before, after ASCO my rose colored glasses are broken

Kab, get that from the fact that nwbo had to raise funds of 2.7 million on July 16 which imo is perhaps enough for 1 to 2 months so figure late August is next logical time, could also be early September. Assume they don’t want to run funds too low. That plus a comment from DI is my homework for this estimate
What is your logic and or homework countering this?

Imo nwbo will need to dilute again by end of August. Was hoping to see the stock hold at $0.23 but seems to be testing the $0.22 level. Hope the next issuance will at least hold $0.20 and w/o warrants, but needs to stop current trend

Meirluc, perhaps nwbo does consider this to possibly be a very complex trial to evaluate and trying to cover many possibilities. Won’t know until the data is out, could also turn out straightforward- virtually all the long term survivors started on the vaccine
As Linda Liau said even if this does not fit traditional measures there still should be a path to approval

Hope we find out this year

Hi HR2, I have been watching nwbo since 2014 and long since 2015 so you have been in longer than me.
I also think there will be approval for DCvax-l in some form if not all, at least for the mesenchymal sub group and methylated. The science seems quite compelling. Just look at the large following here on ihub for a company with under $150 million market cap many have great expectations

I have been speaking with IR pretty much every month for the past 3 years and now convinced another person in our investment group to call as well. He got more info than I thought he would and wanted to share a portion of that here. I do also find that the story from DI sometimes changes so I tried to call him today to triple verify but could not get him

I thought the sap not yet submitted would be something many here would like to know but just created a stir. I share all my conversations with my investor group but only a portion here but much thanks for verifying you heard the same info

My DD on this company is watching every company presentation and saving the slides and posters to go back and reference. Have watched every LP interview I could find starting from 2011. Every presentation from Prins or Liau I have watched at least 3 time each. On pubmed I search and read anything with Liau or Prins or Cloughesy as an author. I appreciate those that go to and report on the ASM.

I do find nwbo to be poor at communication and do not keep us informed of developments. The communication and the large investment by my group is one reason I try to keep calling. I would love to hear a presentation with a q&a at the end

Some say nwbo can’t communicate as just gets used against them but silence has us at $0.23. I have purchased as high as $8.90 and as low as &0.14. I would much rather hear real updates every quarter and have higher confidence and let the AdamF’s of the world say what they may. I will continue to call but may not communicate it here
Good luck

BSB, I posted it was second hand as it was my fellow investor friend that spoke with Innes and to be transparent I stated that. The group, and me in particular have way to large a stake to not try to understand what is going on here
Some just try to share what they have been told and some don’t like what they hear. Innes is certainly willing to talk so don’t understand why people won’t call him when they don’t like what is reported to get the story straight from Innes. Who knows you may get a different story

Does it not bother anyone that a SAP is taking over a half a year. It bothers me. I called IR at another cancer biotech I own and asked if they had a sap in place and the answer was of course they do as they are nearing an end to their phase 3

I’m also waiting for the next quarterly report as of March 31 the balance sheet showed 16 million cash, why this latest stock issue?

Perhaps people will not call because they fear what they may hear and easier to dismiss it
Good luck

BSB, May I suggest you speak with mr Innes and see if you get the same or a different story before dismissing what HR2 and my friend say they have been told. I would be interested to hear the results of your communications with Innes to see if he changes the story

Good point, it is not just fda, it is getting 4 regulatory agencies to agree. I wonder if it is possible to have 4 different SAPs to meet the different ideas from the 4 agencies

HR2, thanks for confirming the information from DI

I am also surprised of no SAP submission yet. Guess the new word has changed from finalizing to “cleaning up”, surprised he did not also say “soon”.
Guess one good thing is that there will be a full 4 years of data on the last patients enrolled. Unfortunately will probably have many small stock issuances to keep the lights on before results

Guess I will stay with hoping for November of this year
Were you here when Rkmatters posted a lot? At the time she was by far the most pessimistic on the timing of results, took some criticism for it and now turns out she was predicting at least two years too early - and still counting

As long as the SAP is taking don’t even want to think how long it could take to submit for actual approval (bla / nda). Year 2021 perhaps?

This is all second hand but I trust this person is relaying info to me to the best of his understanding. One of my group of fellow nwbo investors called Innes this morning asking about SAP status, data lock, and finances.My friend asked what happened to the Sawston $ that was supposed to get us to topline results. DI avoided the direct question and said were working on re-zoning the rest of Sawston to get higher value for possible sale and that nwbo can raise money anytime they need - more shares of course.

DI told my friend they have not yet gone to data lock.

According to my friend DI said they were talking with fda (I took this to mean sap was submitted) so my friend said “so that means the sap is submitted” and DI told him it was not yet submitted.
This surprises me as what would they be talking about if the sap is still being drafted?

My friend said it is quite confusing speaking with DI so not sure all this is accurate but it is what my friend believes he heard. I know I have gotten many conflicting answers that seem to totally change from one week to the next

Wish they could put out a clear status report

I expect the next “news” in August and to be another stock issuance of 2 to 3 million $. And nothing on direct or progress on “L”.
Still hope for results in November, really don’t want to wait for ASCO 2020.
Imo the talk on new direct phase 1 is a diversion as they have no $. So many financings in past years have been “to fund upcoming direct trials and general corporate purposes”. Can really say that only a dozen times or so before even I become suspicious. The stock sales are always to keep the lights on. Need to sell the rest of Sawston

I like that company as well. Big investor purchases, and two phase 3 studies due to read out in next 6 months. Have a small position in it but far larger in Amrn. I wish both success and for me to profit as well. Nothing wrong with krill oil, have seen a couple people do well with it one was able to get off the stantins. V now has much more data behind it

HappyL guess I’m a weak and disloyal long but still maintain nwbo could do a lot more to defend the share value. What happened to the nwbo director saying we can share a lot more in the coming months? Is that this year coming months? I interpreted that to mean we should have had multiple communications by mid July but I see nothing of substance yet and if the director was talking about ASCO, well that was a fail. Perhaps there is a “grand plan” but I’m in the show me mode now. ALL the other small biotechs I have give investor calls with q&a sessions the ceo is promoting the company. Some have had equally disastrous pasts (even worse) as nwbo but management is out there saying what the future holds and when they plan to do with the future. Nwbo MAY be close to something great but tell us where they are, in this case silence to me is not golden. Just myo

In my opinion legitimate shorting is not the cause for the current low price and trying to blame the shareholders is not fair. Nwbo has had to do many toxic financings in which warrants were also issued. I believe this is the source of much of the shorting. Back when I regularly talked with Goldman he often blamed “naked shorting” not legitimate borrow my shares at a cost and sell them short. I have no idea how to do a naked short and don’t know if it is legal. I don’t have a problem with legit shorting and I certainly would be better off if I had shorted at 8+ a share instead of buying, but I don’t short stocks.
More to the point it is the job of management to make investors want to buy a stock and not go short and then blame shareholders for the problem. Most of my shares are in a cash account but some in margin accounts but I use that margin and am not even considering changing them to cash only accounts as I use that margin for many investments other than nwbo.
Management should defend the shares this silence is not a good strategy it has failed for years. The ASCO debacle was so disappointing, they had a chance to lay out a semblance of a timeline and again failed. I have several small biotechs and they all communicate better than nwbo. They could at least say the new draft sap has been completed and submitted to show some progress. I called IR at another similar company near end fof phase 3 and asked if they had sap in place and they acted as if I was crazy - of course they do. Nwbo is so unique

Bosch on June 2nd at ASCO said they had been working on the sap for 5 months and was nearing completion. If working on sap 5+ months that sure seems like starting from scratch. We still are not sure if it completed yet

Well, since they are totally re-writing the sap who can say what the primary or secondary endpoint is? Could they not write a sap to say evaluation on long tail a genetic subtypes? I don’t know, thought the sap should be done as begin a trial not after it is done but nwbo is not traditional

Senti, well thought out scenarios to potential approval. I have one other point to consider and especially the scenario in which both pfs and os were not statistically significant but they long tail of about 1/3 does seem significant. I go back to one of Dr Liau’s presentations in which she speaks about the genetic sub-types and that DCVax seems to help the mesenchymal (sp) group but does little for proneural. The mesc group is roughly 40% of gbm and if DCVax does particularly well in helping this group (at 40%) of all gbm then 1/3 doing so well in this trial could be from this genetic subgroup. Still could see it being approved for all as it does no harm and the mesc group could potentially be enough to make it statistically significant for the entire trial on both pfs and os. Liau at UW speaking most of the long os were still not progressed is also encouraging.

The science is great, now wait to see if nwbo can get a sap agreement and find the funds to get to the end. Thought the Sawston sale was supposed to be enough but clearly not. Hope they have a sap completed and submitted but this is nwbo and the silence on actual progress is the one thing we can count on them for.

Appreciate your post, good work

HappyLibrarian, I also think the small raise is no indication of topline date. I expect another similar stock issuance in late August and another in October and then I hope data release in November
If they could sell the rest of Sawston could avoid at least one sale. Also sceptical on starting the direct Phase 1. If out of $ save it all to get to final data on P3, don’t start something else

Senti, I thought it was Exwannabe that predicted this, thanks for confirming. Ex was correct I was thinking nwbo would have adequate funds to get to top line and obviously I am wrong
They need imo to sell the rest of the Sawston property and get what they can or I fear we will again see new stock being sold every couple months to keep thing going
I had asked Innes a month ago if the next pr we would get would be top line and he replied may get a couple / few before then - guess this is the first of those communications but not what I was expecting. Oh well I may get my chance to buy back the shares I sold, my target is $0.18

Yes dilution again, 11.78 million shares at $0.23
Nwbo must be out of $ again, this sale gets 2.7 million to keep the lights on

Need results so will not have to go back to selling new shares every couple months. Was it Ex that warned this was coming?

Flipper thanks much for this poster presentation that includes the 32 pseudo arm. You spoke of this group in the past and I think it is potentially very important. I have been very much disagreed with but imo nwbo could talk about this group of 32 in a similar way they speak of the main trial of 331. The group of 32 is also blinded but nwbo could still say blended months of survival is a great number and the % that on crossover have received DCVa-L
Innes is worthless but he was promoting to me the results of the 25 indeterminates and then when I asked about the 32 pseudoprogressors that group “is too small to mean anything “. I believe the 32 are very meaningfull and should be a great success unless they did not survive as should be expected and nwbo just does not want to expose this data.
I need to stop, my real question tomorrow is for a person in need of a miracle from direct but so far 0 for 3 and after tomorrow probably 0 for 4

Again get thanks for the poster presentation they had another one a year later I believe also including the 32 and very little after that. This is the group that should have done the best and should brag on unless was a failure

Flipper do you think nwbo could talk about this blinded group of 32 in a similar way they discuss the blinded 331?

Rather interesting how the postings have slowed down Guess all just have to wait to see if there will actually be results. No one even speaks of talking with Innes, think I will tomorrow on a question on direct - will see if I get an an answer

Cherry tree it is indeed challenging to sell a large # of nwbo shares To get this at a more comfortable level in my portfolio after ASCO I had a sell ask for 101k shares out there all day and it was like minnows nibbling not a shark biting. Guess if put it at market would have gone easy but at a sort of reasonable limit price ( well over current price) I made the market all day. Will keep the rest of my shares and look to buy back the rest at $0.18. Hope it does not get there but who knows if no results by September or October I’m confident I can get those shares back cheaper

Very profitable sale or slightly profitable sale I just hope the Sawston sale provided adequate funds to get to phase 3 results without what seemed to be endless small not favorable issuance of stock and warrants. I know they had to have the funds to stay in business but was at a large cost to the now very much long term highly diluted shareholders. After June 2 my optimistic rose glasses broke and now time to speak the truth. I don’t buy the story that telling what is really going on helps the bad guys. Silence has taken us from $12.50 to 0.25, see if transparancy takes us the other direction
May November 2019 give real news

Gary, quite apparently cvm had previous problems but the current phase 3 immunotherapy study started for the current indication (oral cancer) in 2011. Many delays, Adam F bashing, but they communicate, have an existing sap in place ready to evaluate results, and ceo and management purchasing stock with their own money. I only stumbled on them this year and so far profitable for me. Nwbo has had similar problems but lost their market listing and do not communicate. Cvm’s ceo acknowledges had previous problems speaks to investors and welcomes questions. I have been in nwbo a long time but do not see any such communications from nwbo. Not that you can really get much from investor relations but call IR at both companies and share here what impression you get - few do but Ir won’t bite. I get totally different feel between the two. If I were just now discovering nwbo and the Liau presentations and my first purchases were at $0.24 I might be more the optimist. If I knew none of the nwbo history I may think ASCO 2019 was impressive and not a great disappointment. I have a short profitable history with cvm and a very long history with nwbo (not so profitable) so I plan to hold both and hope cvm continues to reward me and that nwbo can sometime turn it around. Imo both have enormous potential just one tells me about it and one lets Linda Liau indirectly speak for them - May both strategies work out. I still think cvm reports top line before nwbo. Good luck to both

Flipper I rather agree the tone here has changed, would be nice if the company could give some real progress report and not with the word “soon” or the always dependable silence

Ex, cvm is quite similar to nwbo but also has some differences. Cvm has presentations given on conference calls and at the end he asks for and answers questions. Similar to what was heard from nwbo a couple years back, cvm is waiting on 298 survival events. Unlike nwbo, cvm claims to have a sap in place and will not have to create one once the 298 os events have occurred. Cvm has had 3 presentations so far this year and at least 2 have had q&a. Cvm in May also issued a letter to shareholders to give an update. IR at cvm is much easier to talk with vs nwbo - no circles or riddles.

Cvm quite similar to nwbo “waiting longer” but will see if when events occur if they use the nwbo let’s wait for something else. I like that they have the sap in place and that they communicate. Imo, cvm will produce top line before nwbo. Their sap target is to show 10% os improvement compared to Soc and they speak this in presentations and shareholders letter. Their phase 2 study (very small and compared to historical data) had 30% os improvement

Nwbo and cvm - similar yes, but also quite different. It would be great to have a nwbo presentation followed by a q&a session

DocLogic I appreciate the answer but am still confused. If pfs comes into play (and from Liau’s last presentation it really could) then the 32 are additional data for the trial of 331? If they can talk of the blinded data on the 331 which has promise then why not the same for the 32 which in theory should be even better? The bad guys have havenearly won, I don’t care if we are at $0.24 or $0.14 I just would like some discussion from management to give a long some confidence

This from a person that started at $8.90 per share initial investment and think it is time for some transparency