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Indeed usually stocks make double bottom before reversing once for good.
Best wishes,
Docinvestor
*SHORT INTEREST UPDATE*
http://www.nasdaq.com/symbol/nwbo/short-interest
At all time high on 11/30 up 600k. Probably some insiders in Nasdaq but unless they were smart enough to cover right after delisting news they lost money during December first half.
Best wishes,
Docinvestor
Spotting pseudoprogression is not simple indeed. I never said it was. On the other hand definition is very simple : a pseudoprogressor is someone that was called progressor in the first place.
Therefore with better criterias you have less pseudoprogressors and the long term survivors in phase 1/2 that flipper believe were pseudoprogressors won't be pseudoprogressors this time because of protocol enhancements. That is why trial may take so long.
Best wishes,
Docinvestor
I disagree, first you need to be diagnosed with a progressive disease then after on a second scan you can be called pseudoprogressive if prior statement was wrong.
With good progression criterias you don't get pseudoprogression at all because what you call "treatment response" or believe it is "treatment response" won't be enough to call a progression in the first place.
Best wishes,
Docinvestor
Progression criterias are not the same in this trial and are believed to ensure more accurate diagnosis as Linda Liau wanted that kind of patients you mention inside rather than outside when she helped design the trial.
Let's not forget that pseudoprogression is not a disease itself but a flaw in diagnosis.
Best wishes,
Docinvestor
4 months PFS benefit would be better than already approved product like Optune, which is very expensive and not a comfortable therapy.
Given excellent safety profile conditional approval is the very very least we can expect if primary endpoint is met. Worst case scenario being that CHMP ask for a confirmatory trial regarding OS if numerical advantage is close non existant.
FYI there is a single agency that approve drugs for whole Europe ex-UK, then it is up to insurers in every country to decide if they reimburse the therapy or not.
I think that FDA will approve it too but it is not guaranteed as they don't have conditional approval mechanism, they've been in a good mood lately for indications that lack coverage (Sarepta for example) so we only have to hope that it doesn't change when Northwest Biotherapeutics file its application.
The blind prevent you from knowing in which group patients are, even Linda Liau can't see crossovers so when she stated that all patients are living longer it may very well mean only those that are in treatment group.
The most important will be primary endpoint, if it is met then conditional approval is guaranteed in Europe whatever are the OS figures as long as there is a numerical advantage for treatment.
Best wishes,
Docinvestor
Remember that in this trial every patient underwent gross total resection. That won't be the case in our phase 3 trial with a fair share of population with only partial resection, the median OS is therefore likely to be shorter than 21 months for placebo group if not accounting for possible crossover effect.
My forecast is that it should be something between 21 months and the median OS of the very large Stupp Optune trial at 16 months. 18.5 months mOS is a good bet in my opinion provided vaccine has no effect after recurrence.
Best wishes,
Docinvestor
You are overestimating their market impact.
The core 10 millions that have been there for a long time won't move but the 3m or so that entered at a very low price are at severe risk of losing infinite money remember that on CPXX they lost 30x their money, imagine you invest 100k dollars you lose 3m, wow I hope I'll never live that.
When they exit it won't move stock price much anyway, we had days with 23m shares volume.
You should understand that short covering is irrelevant regarding future price direction, trials updates will dictate the trend and we have a good start with that combo trial announcement.
Docinvestor
* SHORT INTEREST UPDATE *
http://www.nasdaq.com/symbol/nwbo/short-interest
Near all time high with only 300k shares covered in the first half of November. Notice that it was before the very good news about combo trial was announced.
With upcoming phase 3 results it will be interesting to see if they try to endure some more pain or cover more, remember that their risk is infinite compared to the long side. These are bold traders and even if I am not on their side I admire their courage.
Best wishes,
Docinvestor
Options are too expensive with a giant implied volatility. It is much better to buy common stock as long as it is cheap.
Also...If there is a buyout at $6.50 you will lose everything. There are plenty and plenty of scenarios where stockholders make money and you get broke while the other way around is not possible.
Docinvestor
Where are you DDD ? We miss this skilled timing.
Best wishes,
Docinvestor
"Not always" means that sometimes it happens. If you noticed I gave you an example where estimated primary completion date on clinicaltrials.gov matched results.
They don't have to write a press release to warn us when analysis start, interim or final.
If you have any evidence backing your claim and those that are in contact with Les Goldman I'd be happy to read. Until then I will assume there is high "risk" that we get results any day from now.
Docinvestor
Now that you talk about Rintega from Celldex Therapeutics I found an interesting analysis.
Totally resected patients on Rintega with methylated MGMT promoter and rapid progressors excluded, you can't have a population with better prognosis these are the best of the best, they still had worse outcome than patients on DCVAX-L in phase 1/2. Both in mPFS (17.7 vs 26.4 months) and mOS (32.3 vs 36.4 months).
Docinvestor
You hope on yours I'm ok with that.
Docinvestor
How convenient to all share same conclusions like a single same guy with so little evidence. I wouldn't be so sure, actually my central scenario is that we get results in November. Here is why :
This is a non issue, we all know NASDAQ will accept the plan like last time. DCVax-L success may even be announced before it is resolved.
Notice that management still expect share price to go beyond $1 before December and I doubt this confidence is only backed by Clinton defeat in US presidential elections.
Docinvestor
Example : Celator Pharmaceuticals
https://clinicaltrials.gov/ct2/show/NCT01696084?term=cpx+phase+3&rank=1
How will Northwest Biotherapeutics affect Argos Therapeutics ?
Your analysis is interesting but it will probably be the other way around.
There are good chances that we get DCVax-L phase 3 results before.
Docinvestor
What you fail to see in order to make a fair prediction is that analysis probably already started and November 2016 is the month scheduled for results, exactly like March 2016 was for Celator Pharmaceuticals.
Docinvestor
No warrants attached and at a better price than September cash raise, that is what you call pushing hard ?
If people launch a big manipulative campaign on social media to talk down a stock that is very good sign because non working science don't need that much bashing to fail. The science just fails by itself.
Docinvestor
Results can be published today, we are in November and on clinicaltrials.gov it only says the month.
Here is the Celator Pharmaceuticals trial you are talking about :
https://clinicaltrials.gov/ct2/show/NCT01696084?term=cpx-351&rank=12
Q4 2016 for results is very likely but I agree we may have to wait for Q1 2017. We can't be 100% certain trial is a success but what is sure is that movement in share price will be spectacular and rareley seen before in recent market history (Celator Pharmaceuticals is an example) if we are right.
Best wishes,
Docinvestor
Prior deal 35 cents with warrants coverage, 38 cents with no warrants coverage are better terms.
Best wishes,
Docinvestor
RK and DDD, you both are very good assets for the board but I think you're paying way too much attention to a political sciences major's words.
This offering was very good news as it show the company can still raise money with ease and at better terms, I'm convinced share price will carry on it is emerging recovery.
Some people have been trying to turn good news into bad ones for a long time and it is best to ignore them, investors entering now are no fools as it is much smarter to buy low than high as history showed us many times.
Best wishes,
Docinvestor
Don't worry this is not their first trial, they perfectly know what is allowed to do or not.
Best wishes,
Docinvestor
It is not all that simple exwannabe, changes are acceptable in some cases. If NWBO could provide insurance that optimization didn't affect safety between phase 1 and phase 2 then there is no reason why regulators wouldn't accept.
Now over the course of the trial that is a different story.
Best wishes,
Docinvestor
DDD I don't like percentages as I think that us investors wanting to be successful we should either be convinced or not convinced and hold until we are proven right or wrong, but if I'm really forced to do a percentage prediction with this data I must admit it is very very much closer to 100% guaranteed than to 0% guaranteed.
Remember also that vaccine is probably more effective now than 10 years ago thanks to optimization.
This investment is not a no brainer but even with your simple presentation and knowing that valuations will eventually reach billions in case of success, anyone can conclude that this stock is definitely a must buy for those willing to make great returns this year and next one.
Best wishes,
Docinvestor
This is last buying opportunity before primary endpoint. That investor didn't ask for warrants so I am surprised there was a negative reaction at all but we all know how irrelevant day to day fluctuations are regarding main investment thesis.
Bottoming process get more and more obvious on the chart and I am confident price action will recover from this sell off while people start to realize there is a great reward nearby. Rarely such an effective pipeline had been priced so low by market, all the people that were impressed by Celator Pharmaceuticals recovery going from $1 to $30 in a few weeks have the possibility to live the same story once again.
Best wishes,
Docinvestor
Woodford's Alkermes +48% after success in depression drug trial. He definitely shows he can still spot gems in biotech. Next one succeeding is Northwest Biotherapeutics in glioblastoma multiforme.
Best wishes,
Docinvestor
Kabunushi it doesn't work that way. Theoretically cash raising is neutral to a company value as shares issuance is compensated by more cash flowing into the stock. Most of the time and unless it is a huge offering it is usually irrelevant especially in cancer biotech and most specifically in Northwest Biotherapeutics's case where tens of billions are at stake.
So why do we see many times price action going down after such announcements and sometimes going up ?
It is mainly psychological, when the price of an offering is low existing shareholders are often disappointed by the gift offered to new ones hence the emotional sell off. Same thing when price if high, there is a relief rally because people think it is a bargain to buy under or near at what paid institutional investors assumed to be in the know. But most of the time when it goes up a lot it is because it removes uncertainty on a stock that was in a distressed situation.
Best wishes,
Docinvestor
Dear Mav, what make data from this website so reliable ? It looks like it is made up without evidence.
Best wishes,
Docinvestor
Thanks Mav, let's not forget Roche Tecentriq that presented good results as second line therapy. http://www.bloomberg.com/news/articles/2016-10-09/roche-s-tecentriq-extends-lung-cancer-patients-lives-in-study-iu28jggl
That is really a severe hit to Opdivo this weekend. BMY can only succeed in combo therapies as of now.
Best wishes,
Docinvestor
Wow DDD great post again, thank you so much. We need you to balance F-stein doom and gloom view.
As far as I am concerned I more inclined to the possibility of a sell off in case of failure at least on knee jerck reaction but considering the extremely low market capitalization it is not impossible that big investors would take the opportunity to build big positions for DCVax Direct trials therefore initial losses would be erased as stock price recover from the unlikely news.
Most probable scenario remain a success and I am pretty sure we will see at least three figures performance the day they are announced and perhaps 4 depending on what is communicated.
Best wishes and have a good weekend,
Docinvestor
Kabunushi and Evaluate you are both wrong on this aspect, in Evaluate's mail answer they reiterated that they are no longer subject to Section 16(a) requirements following their switch to a passive stance.
For example check Prothena SEC filings, Woodford never filed a form 4 despite the fact that he owns more than 10%.
Best wishes,
Docinvestor
My opinion is that he will try to remain under 30% ownership.
Best wishes,
Docinvestor
Smokey and DDD both have interesting theories about what is going on.
I am myself quite excited about the possibility of seeing Woodford investing again in this company.
Wishing you all a good afternoon,
Docinvestor
Great article thanks DDD.
I enjoyed in particular how he politely showed that Feuerstein was BS once again.
Best wishes,
Docinvestor