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I know and I realize this but there was definite info provided especially surround German HE and Direct. I have talked with LG before and I will just say that things are looking very bright by years end. Hope you are able to stick it out at least until then
BSB-
I think we will have one big early XMas gift here!! With that being said I am buying more moving forward. I had stopped at current 7K but will now add at these prices. GLTU
Austin-
See my recent post. WE WILL have reimbursement #'s, patient #'s and actual rev #'s by end of Q4.
Here's what I got:
-With regards to PIM out of UK there were actually over 300 applicants of which only 2 met the criteria and NWBO was selected. He said many of these applicant were Big Pharma so the fact NWBO was selected is huge. So, AF twisted this as to appear very insignificant when all be told LG said it is quite significant. He did say there has been alot of buzz/news articles out in the UK on this PIM designation and NWBO.
-Gremany HE negotiations, rev#'s and actual patient #'s being treated will be out by end of year! It sounds like price for reimbursement has mostly been finalized but he could not give me hard #'s. Any facility in Germany, not just the 10 Hospitals that have applied for reimbursement can treat and apply at the time the patient comes in.
-DCVax Direct: Phase I done in Spring but will have another update on data in Novemeber. Early data for solid tumors of the worst cancers are showing striking results...but its early Public info here but he highlighted injected tumor showing tumor necrosis and they are definitely seeing systemic affects. Primary endpoint is tumor necrosis/death observed via biopsy and scan. Phase II will be multiple targeted injections with a similar ramp as we see with Phase I. When asked about Merk/Keytruda...not much info was given other than Direct just doesn't have enough data yet but...there was alot of confidence that all designations that Keytruda received are in our path just down the road (meaning 2015) The worst side effect seen with Direct is slight fever for 1-2 days. BTW...Allan Butler is feeling "great." Obvious local and systemic effect. Two Dr's (not named) are the ones who help put together the Nat Geo clip. Why is this important? Given all the crapola it seems some at MDA are still very supportive and excited about NWBO and Direct. SOP does not allow lead trial investigator to be the one to present data on behalf of NWBO so we won't hear Subbiah doing such. Moving forward data release from Direct will be coordinated with MDA for obvious reasons.
-DCVax L: Enrollment complete by end of next year. Hospitals are paid and costs are occurred to have trials there but there have been NO issues surrounding this. Compassionate/Info 51 arm is a mix of rapid and pseudo progressors. These patients were the worst of the worst and to date, the OS is 18 months but "many" are 23-24 months OS. This arm will be used as a subgroup to show effectiveness of Tx with L with patients on Hospice doorstep. Given enrollment completed by end of 2015...data release and hopefully approval in 2016.
-Prostate Trial: Focus has shifted to Direct and not much new info here.
-Couldn't get too much into Big Pharma interest but they continue to attract ALOT of attention??? He said this can be a good and bad thing No other Pharmaceutical Company has done what NWBO is doing in Europe...they are way ahead of the rest!!!
-Institutional ownership is tricky...some come onboard for only a short period of time and others are invested long term based on what the company is doing.
-Believe it or not...they have multiple "small" PR firms on board already. This is where it got comical. Given the sheer float/short % it is a constant uphill battle and they are well aware that any positive PR will be met with attacks. The reason they respond to AF is to answer to the shareholders that their science is sound and positive data is see. He understood that this somewhat fuels the fire for AF but being a lawyer...he is not going to sit back and see attacks misrepresent the facts. Nothing legally can be done at this point but other groups aside from CREW are taking notice of AF and other short tactics.
The conversation started at 11pm PST so I wanted to be respectful of how late it was on the East Coast. I didn't get to all of my questions but I have a good rapport going with LG.
My key takeaway...between now and end of Q4 is going to be big and longterm...multibagger
Great conversation with LG, just got off the phone. Will fill you in after I get some shut eye. Nothing that isn't already public was discussed. He is a good guy and certainly is passionate about what he is doing.
Key takeaway: Very very good news by years end and update on Direct results at conference coming up in November.
With that I bid you a fond farewell....................
I will add that to my questions for LG
Will also try and get some details on the $17.5 convertible note offering
Just got off the phone with LG....he responded to my email from this am and told me to call him.
He was getting ready to sit down for dinner when I called so I will be calling him back when I get home from a dinner party tonight.
Here is my current questions to ask LG:
-German reimbursement negotiation process, i.e., what is the typical timeline, how does it work, who makes the decision, is there a ratification cycle in German gov't, etc. BSB's comment on getting a ballpark pricing, even if it was a wide range, would also be welcome info. As well, more precise info the ramp of German sites would be welcome.
-Any expectations on revenue from self-pay patients. Q3 should see some of those, as the Dresden site opened in June.
-Comments on the recent AA on Merck's PD-1 drug after only Phase I results vis a vis DCVax-Direct - that is, is NW planning on pursuing AA and if so, how. IMO it seems DCVax-Direct will be on a path to demonstrate superior efficacy to the Merck drug, but with far fewer than the 89 patients in the Melanoma cohort of the Merck drug.
- Any detail on PhIII enrollment status, more precise dates next year for full enrollment, or perhaps easiest for NW to answer, what is the expected time lag from full enrollment to top line results available and why is that the estimate.
-Where do you stand with Prostate trial and are you looking for a partner
-Big Pharma interest level
-Lack of big financial institutional ownership
-Hiring a PR firm and why continue to respond to AF?
Any other input or questions and I will get as much as he is allowed to give me!
Thank you Master
Breath taken I don't think it is unreasonable for shareholders to hold CEO's or the Companies they invest in accountable.
We/shareholders were told that a $30M deal would be announced in Q3. Well...I for one partially invest on the guidance and forecasts and if we are told of such facts then I expect that to happen.
Maybe dkhead was a little obtuse but the fact remains...how about some news on that deal in Q3? Cheap words are counter productive in my world.
Hope that was enlightening. GLTU
BioBird got his feathers plucked by Pyrr
Hopped in a .178..just wish I had done more than get my toes wet
Go get em' Flip!!
I did email LG this am regarding the issues that have been discussed here. I will certainly let you know if I hear anything but I am not holding my breath.
Yep...just another dkhead CEO move!
Sorry STT but AF no longer has any credibility so there would be nothing legitimate on his end.
Timing of PR's from LP...so releasing data is now considered pumping yet you favor false, misleading claims from a yellow journalist?
I hope you have a better plan of action than this
Still in it for the long haul!
You would squirm...u got that one down All in good humor Pyrr...it can be crippling to know everything
That was a good call though! For the time being this could get dragged down much lower I don't expect any significant news til end of Oct beginning of Nov. GLTA
It really is hard to believe we are well under $5 again. Pyrr would spin this as into a + and that the pps is irrelevant. Just the same, its hard to sit back and watch this get dragged down time and time again.
Positive news is on the horizon but so are the attacks!
Flip-
Late at night on my end but just getting home from a "boys night out."
Great from the heart post and I personally thank you for a brief glimpse into the person behind the posts!!
Hahaha...what a joke. My posts along with others are being deleted from the comment section in the Streets article from Janet Guyon.
No problem, I just repostI also sent these posts over to Steven Pearlstein at WP
88K shares purchased AH at $4.59.....
Of course it doesn't have to be today....just wanting one of these CEO's to stick to their word and timelines I certainly can wait this one out but the sooner the better!
If we don't get a PR from Marsh on this $30M deal today...I'm heading out to the garage for my TaylorMade driver and I'm gonna aim one right at Andy's yahoos
Just sent it to Steven P Also sent Janet Guyon a private email highlighting case against AF. Also made here aware that I along with other have contacted high ranking government officials regarding AF's obvious tactics here.
Following up on the great work by Steppenwolf, I just posted this on the street's article by Janet Guyon:
I would like your take on your non biased, veteran reporter
Adam Feuerstein’s positively glowing article on Bluebird Bio dated 06/14/14 titled, “Blood Disorder Patients Respond Strongly to Bluebird Bio Gene Therapy.” Striking results on two patients? Wow, two patients constitutes striking results?
I would like to refer to the PR release by NWBO on 06/11/14
updating early results of their DCVax Direct trial titled, “DCVax-Direct Trial Update Indicates Further Positive Responses; 3 Case Studies Show No Live Tumor Cells In Injected Tumors.” In this PR, early data is given on 20 patients in the trial with very encouraging and positive results being shown. Wouldn’t this warrant a positive article by your savvy, unbiased, veteran biotech reporter? Guess not…instead he went on the attack again and he has time and time again when NWBO announces any positive PR’s.
Back to Bluebird Bio. It’s ironic that Bluebird Bio’s PR Company
is Pure Communications, Inc. and their VP of Media Relation is Dan Budwick. Why is this ironic? Well, here is a tweet on September 28, 2014 by your unbiased, veteran reporter Adam Feuerstein: “Lovely way to spend day with my friend and fellow Yankees fan @DanBudwick. Thank you, Captain. #2.” Followed by another tweet, ! @adamfeuerstein earns Red Sox tix w/ @DanBudwick after promoting Bluebird, Celldex & other Pure client’s @jimcramer.
Now I see where you are coming from Janet in defending your
unbiased, veteran reporter Adam Feuerstein. He obviously is a very ethical reporter who has no bias in any of his articles.
I certainly look forward to your response on this as well as
your response on the disingenuous statement you made regarding NWBO’s interim
analysis.
My response to Janet Guyon:
Good to see you're digging the hole a little deeper Janet. AF's continued false claim regarding the interim analysis and NWBO withholding information has been put to bed by the Chairman of the DMC. Maybe you didn't get the newswire? Here it is for your review:
This AF allegation led to an unprecedented statement by the
obviously outraged Chairman of the Data Monitoring Committee; this is an independent committee of leading physicians and academics charged with monitoring safety and efficacy in the phase 3 trial that has no connection to Northwest. The Chairman sharply rebuked the blogger (AF). He said that there had been no interim analysis for efficacy of the phase 3 trial. He said that
the DMC has not provided any access for the Company to any clinical trial data. He said “that it is surprising and troubling to see inaccurate claims being made by commentators (the prominent blogger AF) who seem to lack a fundamental
understanding of clinical trial monitoring. I have been on DMCs for more than 60 clinical trials, and I have never experienced this type of attack.”
So Janet, by continuing to back up AF's position by stating, "NWBO chose to release news regarding the German approval to distract attention from its failure to release an interim analysis of a critical U.S. clinical trial," are you implying that the chairman of the DMC is lying and covering up for NWBO?
Well played hand Janet! This is only the beginning and glad to see you are willing to throw yourself into the hole with AF...good luck with that strategy.
Arby-
Ummm...end of Q3 is end of Sept.??
TZOR-
Plug lift off??????
You can certainly count me in. I will use all my resources for such a worthy cause Seems like we have a board full of amazing resources and the ball is already rolling!
My complaint I just filed with SEC:
There is obvious manipulation and naked short selling against biotech company NWBO. Since September of 2013, NASDAQ reports that the short interest on Northwest has increased from 635.000 shares to 8,000,000. Some observers have estimated that naked shorts could account for an additional 4,000,000 shares. A prime instigator for this manipulation and shorting has been promoted by Adam Feuerstein of the Street who has a vendetta against NWBO and its management. He has written 19 negative blogs on the company just since March 2014.
I wanted to bring to your attention an article that came out in the Washington Post yesterday by Steven Pearlstein regarding market manipulation against biotech company Northwest Biotherapeutics, Inc (NWBO). Here is the link to the article:
http://www.washingtonpost.com/business/northwest-biotherapeutics-stock-woes-highlight-the-harm-of-short-sales/2014/09/26/78b99b0a-4507-11e4-b47c-f5889e061e5f_story.html
This blatant market manipulation was also recently addressed by Melanie Sloan/Citizens for Responsibility and Ethics in Washington in a letter to the SEC. Here is the link:
http://www.citizensforethics.org/legal-filings/entry/crew-sec-investigation-manipulation-drug-company-biotech-stock-feuerstein
How sad is it that promising and potentially lifesaving treatments in medicine from small cap biotech companies can essentially by shut down due to this blatant manipulation...all in the name of money to be made instead of potentially saving lives.
I just sent this email to a close acquaintance of mine who is a congresswoman in Wa state:
Suzanne~
I hope this email finds you in good health as well as finding that important "balance" of work and family As you are probably aware, my family and I moved down to Bend, OR just over 2 years ago because I had completely lost this balance of work and family. I hope Kurt and the kids are doing well and please tell them Hi for me.
I hope I am not overstepping any boundaries but I wanted to bring to your attention an article that came out in the Washington Post yesterday by Steven Pearlstein regarding market manipulation against biotech company Northwest Biotherapeutics, Inc (NWBO). Here is the link to the article:
http://www.washingtonpost.com/business/northwest-biotherapeutics-stock-woes-highlight-the-harm-of-short-sales/2014/09/26/78b99b0a-4507-11e4-b47c-f5889e061e5f_story.html
This blatant market manipulation was also recently addressed by Melanie Sloan/Citizens for Responsibility and Ethics in Washington in a letter to the SEC. Here is the link:
http://www.citizensforethics.org/legal-filings/entry/crew-sec-investigation-manipulation-drug-company-biotech-stock-feuerstein
How sad is it that promising and potentially lifesaving treatments in medicine from small cap biotech companies can essentially by shut down due to this blatant manipulation...all in the name of money to be made instead of potentially saving lives.
I am not sure if you are able to do anything from your end or at least bring this to the attention of the appropriate people or committees? I appreciate any input or assistance you can provide.
Regards,
Scott
As I stated in my comments on the Post article...our market is a reflection of what our society has and is becoming. It apparently is more important that money be made than lives saved! It makes me sick to my stomach
Very nice work Rk!! Obviously we should all be using our contacts to distribute this article
abp-
My take on your question:
Decent premarket activity! May we see 6-7 range soon..GLTA