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Thursday, June 17, 2021 2:56:21 AM
Some things didn't change.
TLD announcement. No plan. No timeline. No estimate.
No publication.
No confirmation that nwbo itself is unblinded.
No BLA or equivalent anywhere
Data lock happened. Dave Innes told investor
"[we] intentionally gave no timeline, because [we] would not be able to update [investors], if TLD took longer than expected.”
In data lock PR October 5th. NWBO wrote
The statisticians will proceed as quickly as possible with analyses of the raw data and prepare summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, who will analyze the data with the statisticians in preparation for public announcement and scientific publication.
In PR March 16th. NWBO wrote
This Phase III trial is now completed and locked down, with announcement of top line data expected in the coming months.
At ASM May 18th LP said
"As I think everybody knows, back on October 5th [2020] we outlined the process that we would be going through to get to the stage where the results can be announced. And I want to assure everyone that the Phase III trial and the analysis of the data are the most important topic that everyone in this company is focusing on. It has the full focus and attention of our management and our Board as well. Every resource we have has been and is being brought to bear on it. As we say, ‘it is our number one, number two, and number three priority.’ There’s nothing more important to the company. I’d like to be able to go into the details that we know everybody is craving, and understandably so, but we are in a quiet period now, while the data are being reviewed and analyzed. We’ve explained the process that we’re going through, it’s six stages of various analyses and reviews by various parties. And I can assure everyone that we are committed to completing this full process that we outlined at the outset, back when we did data lock. And we are doing so with great care."
In PR May 12th. NWBO wrote
"The process outlined in the Company’s October 5, 2020 announcement relating to the Phase III trial of DCVax-L is continuing to move forward. The process includes review and analysis of the raw data by independent statisticians and experts, and preparation of summaries of the Trial results for review by the Company, the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts in preparation for public announcement and scientific publication.
The Company continues to be in a quiet period while this process is under way. The Company appreciates shareholders’ patience, and their understanding that the Company cannot make partial disclosures during this process and cannot comment on the Phase III trial schedule or its data until the announcement of the results."
I guess its safe to say, that NWBO has continously stated since October 5th. they were now in quiet period and not able to update investors if it takes longer than expected.
They have continously mentioned the 6 stages and that the endgoal was TLD and a publication.
That they are unblinded is a fact, given that March 16th. explicitly wrote "TLD in coming months" and that they April 1st. were able to hire Kristyn Stewart, who would never had agreed for a job, were she would not be needed if the trial was not a success. Stage 3 must therefore have come to an end March latest. Add to this the addition of yet another uplisting expert in May, so NWBO now cover two choices of stock exchanges - NASDAQ or NYSE - and it doesn't exactly look as if they believe, catalysts are in line for making an uplisting possible.
No one knows about the state of BLA, FDA approval, RTOR, ORBIS because of the quiet period above, but the possibility of NWBO having done parallel work and having progressed in "this area" is kind of great.
Frustration due to the waiting?
Yes!
Pessimism regarding the outcome?
How the f... could anyone have concerns about the outcome ... besides the two stooges LC and EX?
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