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Today's action total manipulation of NWBO it is hard to fathom how easy they make it look!
I understand Chris but he actually asked me for a couple of dates and times which I gave him and did not hear back from him. I do understand they are very busy and the reason why I have not chased him at this point.
Thanks for the advice as I know you speak to him fairly often.
Jim, that is possible but IMHO do you think Cognate would be hiring a Head of Manufacturing around the time the new equipment was arriving? Cognate has always noted their client with a Phase III international trial was using the majority of their capacity.
I could be wrong but when putting the pieces together it looks pretty convincing to me. I plan on asking this question when Les calls me back and that is if and when he calls me back. Hope I am right too!
There have been some great finds on this NWBO board that are leaving a 'breadcrum" trail. The shipments that arrived here in US recently for (9) units for clean room biologic equipment for Cognate plus the recent advertising from 3 days ago by Cognate for "Head of Commercial Manufacturing".
Pretty interesting recent discoveries on this board! Why would Cognate be purchasing (9) large clean room biologic machines for large scale manufacturing if a commercialization deal for NWBo/Cognate was not imminent in near future?
JMHO
Sure looks that way to me with all the clean room equipment (9) units, Head of Commercial Manufacturing job posted 2 days ago by Cognate, the NICE appraisal in UK....tic toc tic toc!
Here is the link just posted 2 days ago!
Head of Commerical Manufacturing - Biotech at Cognate BioServices, Inc.
Memphis, TN 38118
http://job-openings.monster.com/v2/job/View?JobID=180706558&MESCOID=1900254001001&jobPosition=1
Great posts on this topic!
No I do not but with all of my due diligence as well as many others on this board it is of my opinion this equipment is slated for NWBO as this is consistent with preparation for a scale up commercialization effort.
This is just my opinion only.
Pretty telling clean room equipment in that quantity and (2) shipments which obviously where they would use (1) system testing and for regulatory evaluation and stringent testing. NWBO would not order (6) units without some form of a plan for approval...IMHO!
Patience is a virtue.....
Just google Cofer Black and I think you will see he is very experienced, very well connected with current government agencies and will "pull the trigger" when his investigation is complete on Knight and naked shorting/manipulation.
http://www.dailymail.co.uk/news/article-3318493/Cofer-Black-George-Tenet-say-Bush-administration-ignored-CIA-terrorist-warnings-two-months-9-11.html
Great post and very well stated!
I am waiting on a call back from Les and it will be one of my questions for sure. I agree wholeheartedly with you on this.
I believe something big going on in UK with NICE appraisal and hope I am right....we should know pretty soon as the appraisal end date I think is Friday, February 17th?
BSB, great post! Have you tried talking to Les?
He will be in my thoughts and prayers as GBM is such a terrible cancer. My neighbor in the town where I grew up she just passed away last week due to GBM leaving a beautiful family behind. I agree with you, the regulatory agencies need to move quicker for better treatment options like DCVax and just a shame these innovative small biotechs get attacked to cripple their innovation, stop getting their product to market and put them out of business by crooked Wall Street.
DCVax Direct is a perfect example with a pristine safety profile and results from the Phase I/II should be available to patients especially with all of the stage IV patients who had failed 3-4 other treatment options many are still alive today such as Allan Butler. Just a disgrace this can actually happen.
Sunday, February 12, 2017
My Northwest Biotherapeutics (NWBO) PFS estimated Kaplan-Meier Chart
Below is a copy of my analysis on NWBO's Phase3 clinical trial that I posted on Twitter back at the beginning of January 2017.
My analysis predicted a likely positive outcome for the trial's primary endpoint of Progression Free Survival (PFS).
http://askthebranko.blogspot.com/2017_02_01_archive.html
Hilarious Senti!
Here is a quick snapshot at bottom of my post of current PPS and Market Cap and scale upwards in Market Cap and PPS without any further dilution. If DCVax-L is statistically significant and gains approval for GBM in US, EU and Canada, NWBO market cap goes to $10-15 billion if approved and this does not include DCVax-Direct for all inoperable tumors.
The market will really wake up once an approval is granted which in my personal opinion believe NWBO will obtain in the very near future!
NWBO MC PPS Out Shares
61,600,000.00 $0.40 154,000,000.00
154,000,000.00 $1.00 154,000,000.00
770,000,000.00 $5.00 154,000,000.00
1,540,000,000.00 $10.00 154,000,000.00
3,080,000,000.00 $20.00 154,000,000.00
4,620,000,000.00 $30.00 154,000,000.00
6,160,000,000.00 $40.00 154,000,000.00
7,700,000,000.00 $50.00 154,000,000.00
9,240,000,000.00 $60.00 154,000,000.00
10,780,000,000.00 $70.00 154,000,000.00
12,320,000,000.00 $80.00 154,000,000.00
13,860,000,000.00 $90.00 154,000,000.00
15,400,000,000.00 $100.00 154,000,000.00
Great post cannonblack, very well said!
RK, another very well stated post on this subject.
Flip, you are so spot on with your posts and very well said!
TC, totally is agree with you on this point. I would like to see an up front payment for combo trial with a partner or another Woodford type investment above market. IMO if NWBO had an experienced CFO with relationships to the investment banking community NWBO would have this investment with an international Phase III trial nearing completion and as Dr. Liau presentation showing promising results coming soon . This is just my opinion.
Great post highwayman! IMHO, this process has been going on since July 2016 (screening halt Aug 2016) and based on NICE appraisal decision due complete in February 2017 which tells me NWBO has submitted everything and NICE Advisory committee is reviewing since January 26th and will make their decision this month.
This could be the start of regulatory approvals in UK, Germany and US.
Great post Senti and really interesting points you have made here!
I like your L2/L3 posts on what is happening on buy/sell side. You seem to be right on point with where it is headed. Thanks for sharing this information.
I like the last line as well...
Thanks for sharing your experience as an oncology surgeon on this as I posted Dr. Black abstract from 2009 on DCVax. Many longs on this board appreciate your and iwasdiver posts as you are both physicians with experience and knowledge.
Dr. Keith Black was involved with DCVax as you can see from his abstract back in April 2009 so possible this patient most likely could have been on the vaccine.
Yes it does....good call jdheart101!
highwayman....great reminder on the benefits of this partnership with Cognate and TrakCel!
There are many irons getting hot right now and just get the feeling/vibe we have a catapult of positive PR's coming with the DCVax-L Phase III trial reaching its endpoints and data lock.
I also believe FDA is also deeply involved in this trial as there is a dire need to improve PFS and OS for GBM and brain cancer patients which the most aggressive of cancers today.
This is just IMHO!
Great post Flip! I do remember LP speaking about cost effective manufacturing efficiency and ability to produce DCVax in 3 year supply within 10 days and now with closed end automation it will improve even more.
Happy, I think you are underestimating the potential upside if NWBO gains approval in EU, US and Canada for brain cancers plus label extension on other operable solid tumor cancers. When DCvax-L approved buyout offers will come and have multiples above the GBM valuation for US, EU and Canada.
Here is simple Market Cap and PPS table with 15M Shares Outstanding:
NWBO MC PPS Out Shares
61,600,000.00 $0.40 154,000,000.00
154,000,000.00 $1.00 154,000,000.00
770,000,000.00 $5.00 154,000,000.00
1,540,000,000.00 $10.00 154,000,000.00
3,080,000,000.00 $20.00 154,000,000.00
4,620,000,000.00 $30.00 154,000,000.00
6,160,000,000.00 $40.00 154,000,000.00
7,700,000,000.00 $50.00 154,000,000.00
9,240,000,000.00 $60.00 154,000,000.00
10,780,000,000.00 $70.00 154,000,000.00
12,320,000,000.00 $80.00 154,000,000.00
13,860,000,000.00 $90.00 154,000,000.00
15,400,000,000.00 $100.00 154,000,000.00
Absolutely as well as expansion at Fraunhofer, and Cognate's $9M Memphis expansion says approval and COMMERCIALIZATION coming soon!
Make sure you re-read Longfellow95's post a couple of times enclosed below as he has taken key points out of this NICE appraisal and highlighted them below as noted in the first line of his post#99862:
I am not sure, I would bet we have someone more qualified than me that could answer that question if it has not already been addressed in another post.
Great news and very encouraging!
GLTA NWBO patients, families and shareholders!
Longfellow, great summary you have provided on this appraisal highlighting key points.It all seems to now be coming together for NWBO as this Phase III international trial is closing in on completion and published results.
Thanks BSB, looks as though the UK appraisal for DCVax-L is dated January 26, 2017- February 23, 2017 so it is current.
Came across this which I found interesting, scroll down and DCVax is list and not sure what this about but includes a couple of attached documents. Link is at the bottom.
Proposed technology appraisals
These are the topics which the National Institute for Health and Care Excellence has been invited to appraise.
For each proposed appraisal, the table gives the suggested remit, the dates of the consultation on that remit, an e-mail address to send any enquiries to regarding the proposed appraisal, and links to any documents being consulted on in addition to the suggested remit.
DCVax-L for treating newly diagnosed glioblastoma
Suggested remit
To appraise the clinical and cost effectiveness of DCVax-L for newly diagnosed glioblastoma multiforme.
Consultation on suggested remit, draft scope and provisional matrix of consultees and commentators
26 January – 23 February 2017
Batch
50
ID number
836
Scoping workshop
No workshop - consultation only
https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance/proposed-technology-appraisals#DCVax-L
This paragraph is pretty telling where treatment is headed IMO
I agree Chris and regulators will want this plan in place for approval and most likely when screening halt occurred in 2015 we saw the move to significantly increase DCVax manufacturing capacity at Cognate in Memphis, King's College Hospital, Fraunhofer in Germany and the investment in Sawston in the UK was a telling sign. I would expect these expansions are now complete and could be part of approval in US/EU and Canada for commercialization of DCVax-L for brain cancers. JMO!
This is from the link you embedded in your post on Commercialization....great reminder Chris.