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Definitely sounds like she is unblinded. Not sure how she can say anything differently to academia than she could say to investors, and honestly, the scientific community can probably glean even more from her comments no matter what she says. So, unless they are prohibited from investing, seems like an unfair advantage.
Slow trading Friday afternoons with no expectation of news are always my concern. Will people load up or sell off for EOD.....
I'm waiting for the Friday lunchtime bear raid and ready to load up in the $1.35 range.
Anyone reach out to DI for any updates on new hire, ASM, 10K clarification, anything?
No chart this time? Magic 8-ball prediction?
No PR on this hire? Or, did I miss it yesterday?
No pre-market run up this morning. Hopefully a good sign!
Doubtful. No buyout options until after topline IMO.
The premarket prints at higher levels, then drop it. It makes the daily candlesticks look worse than they are....Manipulation.
Easy to keep this down on the low volume. Whether you believe it is MM's or shorts or aliens, doesn't matter, there is no new interest here. Just longs waiting for topline. Mgmt silence prevents new buyers. Without news....we tread water, slowly going under.
No Manipulation? 50,000+ shares, .10 over previous close and now we are down Ridiculous.
Dec 24th we broke back above 50DMA and shot up. March 15th, same thing. This is the third move back up over 50DMA, should bring some buyers.
Now $1.54/$1.58?
Same as yesterday, premarket buy of 5,000 shares .08 over previous close. Coincidence?
ASCO Dates, maybe we see next info on April 28th?:
FEBRUARY 17, 2021 at 11:59 PM ET
Abstract Submission Deadline
MARCH 18, 2021
Late-breaking Submission Deadline (Abstract placeholder is required by February 17 deadline)
APRIL 1, 2021
Abstract Notifications sent to First Author
APRIL 11, 2021
Abstract Withdrawal Deadline
APRIL 28, 2021
Abstract Titles Released
APRIL 28, 2021
Early Registration Deadline
MAY 14, 2021
Exhibits, Industry Expert Theater, Pharmaceutical Pipeline Directory, and Clinical Trials Directory Opens
MAY 19, 2021 at 5:00 PM ET
Abstracts Released on ASCO.org
Has anyone contacted DI or LG for an clarifications on 10K? Fast track? SAP? ASM? Linda Liau presentation coming up?
Correct. That's why the other Risk factors talk about limited mgmt, limited experience scaling a biotech, limited resources, etc, etc. ALL point to a Buyout as soon as topline, IMO. They cannot go it alone and partnership limits return IMO. Takes longer and tied to other company's efforts.
That, if true, would be significant. However, if the sale of shares throughout 2020 simply brought her ownership percentage below that threshold, then it's nothing. And, if LP no longer controls shares...by sale or transfer, they would have to disclose.
How do you know that is what he was referencing? He said "read it in it's entirety." Anyone who does that and compares to what was stated last year is not referencing something that did not change. And, he said 95% chance of approval in UK.....nothing to do with FDA fast track.
Run? Low volume and headwinds on offer again. Aren't going anywhere without much, much more buying. And, news....
Agree. Neither am I! I think he is saying, read between the lines, we have a 95% chance of approval.
Agreed. However, they could have left the language the same unless they thought it was material enough to change and unless they felt like there was even tacit acceptance by RA's. IMO. If they got a lot of pushback from RA's, I don't think they would state the risk factors this way. They still have to say there is no guarantee they will get approval but this is stating they believe they will be judged on new endpoints.
Point is that 2019 vs. 2020 10K Risk factors changed. When Bigger says read 1.A in it's entirety, these are the items that really changed. It's a positive acknowledgement that the SAP was submitted to all, and as per LP, we wouldn't go to data lock without buy-in from all 4 RA's. Still have to assume there is a lot of risk with data and approval. But, this is what I believe Bigger was referring to. IMO.
2019 10K Language in risk factors 1.A:
We may not receive regulatory approvals for our product candidates or there may be a delay in obtaining such approvals.
Our products and our ongoing development activities are subject to regulation by regulatory authorities in the countries in which we and our collaborators and distributors wish to test, manufacture or market our products. For instance, the FDA will regulate our product in the U.S. and equivalent authorities, such as the MHRA and EMA will regulate in Europe and other jurisdictions. Regulatory approval by these authorities will be subject to the evaluation of data relating to the quality, efficacy and safety of the product for its proposed use, and there can be no assurance that the regulatory authorities will find our data sufficient to support product approval of DCVax-L or DCVax-Direct. In addition, the endpoint against which the data is measured must be acceptable to the regulatory authorities, and the statistical analysis plan for how the data will be evaluated must also be acceptable to the regulatory authorities. Under the Protocol for our Phase III trial of DCVax-L for Glioblastoma brain cancer, the primary endpoint is progression free survival, or PFS. Sometimes regulators have accepted this endpoint, and sometimes not. There can be no assurance that the regulatory authorities will find this to be an approvable endpoint for Glioblastoma multiforme cancer. In addition, as previously recognized, the PFS endpoint in our Phase III trial is complicated and potentially confounded by the phenomenon of pseudo-progression, in which a patient appears to have disease progression (tumor recurrence) but does not actually have such progression (for example, where the appearance of progression is actually inflammation or scarring, or is infiltration of beneficial immune cells). Under the Protocol for our Phase III trial the secondary endpoint is overall survival, or OS. There can be no assurance that regulatory authorities will find a secondary endpoint to be an acceptable basis for product approval. In addition, as previously recognized, the OS endpoint in our Phase III trial is complicated or confounded by the trial design, which allowed all patients (including patients initially assigned to the placebo arm of the trial) to “cross over” and receive DCVax-L treatment after recurrence of their tumor. These factors could result in regulatory authorities refusing to accept either of these endpoints, or the analysis of our data relating to either of these endpoints, as a basis for approval.
The time period required to obtain regulatory approval varies between countries. In the U.S., for products without “Fast Track” status, it can take up to 18 months after submission of an application for product approval to receive the FDA's decision. Even with Fast Track status, FDA review and decision can take up to 12 months. At present, we do not have Fast Track status for our lead product, DCVax-L for GBM. We plan to apply for Fast Track status, but there can be no assurance that FDA will grant us such status for DCVax-L.
Different regulators may impose their own requirements and may refuse to grant, or may require additional data before granting, an approval, notwithstanding that regulatory approval may have been granted by other regulators. Regulatory approval may be delayed, limited or denied for a number of reasons, including clinical data, the product not meeting safety or efficacy requirements or any relevant manufacturing processes or facilities not meeting applicable requirements as well as case load at the regulatory agency at the time.
2020 10K Language in risk factors 1.A:
We may not receive regulatory approvals for our product candidates or there may be a delay in obtaining such approvals.
Our products and our ongoing development activities are subject to regulation by regulatory authorities in the countries in which we and our collaborators and distributors wish to test, manufacture or market our products. For instance, the FDA will regulate our product in the U.S. and equivalent authorities, such as the MHRA and EMA will regulate in Europe and other jurisdictions. Regulatory approval by these authorities will be subject to the evaluation of data relating to the quality, efficacy and safety of the product for its proposed use, and there can be no assurance that the regulatory authorities will find our data sufficient to support product approval of DCVax-L or DCVax-Direct. In addition, the endpoint against which the data is measured must be acceptable to the regulatory authorities, and the statistical analysis plan for how the data will be evaluated must also be acceptable to the regulatory authorities. The statistical analysis plan that we submitted to regulators for the Phase III trial embodies a different primary endpoint and secondary endpoint than did the original Protocol for the trial. Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design, which allowed all of the patients in the trial to cross over to DCVax-L treatment after tumor recurrence (while remaining blinded as to which treatment they received before tumor recurrence). The statistical analysis plan uses external control patients rather than within-study controls. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach.
The time period required to obtain regulatory approval varies between countries. In the U.S., for products without “Fast Track” status, it can take up to 18 months after submission of an application for product approval to receive the FDA’s decision. Even with Fast Track status, FDA review and decision can take up to 12 months. At present, we do not have Fast Track status for our lead product, DCVax-L for GBM. We plan to apply for Fast Track status, but there can be no assurance that FDA will grant us such status for DCVax-L.
Different regulators may impose their own requirements and may refuse to grant, or may require additional data before granting, an approval, notwithstanding that regulatory approval may have been granted by other regulators. Regulatory approval may be delayed, limited or denied for a number of reasons, including clinical data, the product not meeting safety or efficacy requirements or any relevant manufacturing processes or facilities not meeting applicable requirements as well as case load at the regulatory agency at the time.
5000 shares pre market at $1.485. Here we go with the rollercoaster again.
Would be a great timeline! While it is encouraging that the 10K was on time, they need to back it up this week with more positive news and path forward. No more tea leaves!
Once again, days of parsing and even more speculation since we hear nothing from the company. I am sticking to my (just as valid as any other) prognostication: Since the 10K was actually on time, next news will be ASM notice. Hopefully next week! It will state an actual date about 6 weeks from notification. That will be the window, IMO, when we see topline.
This is what matters, but still doesn't say EXCATLY where we are:
"On October 5, 2020, the Company announced that Data Lock for the Phase III trial had been reached, and that a series of steps and processes would follow. These processes included data validation, analyses of the data by independent statisticians, preparations by the statisticians 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 publication in a scientific journal and public announcement. This series of processes is under way. It is anticipated that public announcement will follow these processes."
So, where are we?
Done, IMO: "data validation, analyses of the data by independent statisticians, preparations by the statisticians of summaries of the Trial results for review by the Company"
---This means we would be unblinded when completed.
In Process, IMO: "the Principal Investigator, the Steering Committee of the Trial, the Scientific Advisory Board, and a panel of independent brain cancer experts, in preparation for publication in a scientific journal and public announcement"
I retract the "not unblinded by 12/31/2020" statement. And FeMike, I don't believe the risk factor text as current status, it has been stated like that for a while, it's boilerplate.
If it said anything in subsequent events, I would believe it. What I find possibly interesting, reading the tea leaves, is the multiple use of the same paragraph citing covid delays. Limited staff, etc.
"As also previously reported, coronavirus-related difficulties have impacted most aspects of the process, especially with the successive waves of COVID cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial site personnel have been unavailable due to being reassigned for COVID, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses, continue to have only limited operations. Even logistical matters such as the shipping of materials have been, and continue to be, subjected to substantial restrictions and delays"
So, once data is collected and locked (October 5th), when would you need to start shipping tissue samples? The CRO has them and is only responsible for compiling the data. You would only need to start shipping tissue samples when Company is unblinded and you need to get those samples to SAB, Outside experts, etc. Right?
Important because we are 6 months post data lock and nwbo mgmt continues to leave shareholders in the dark as to where we are. Unblinded? Close to Journal article? Topline?
Given that they continue to blame covid, which is valid to a point, wouldn't those delays be material and deserve a clear update?
In any other time (No Covid), we would have had topline by now, IMO. Therefore, covid has had a material effect on shareholder value. PPS could be 10 times higher if data is good.
Positives of 10K:
They filed on time
Warrants suspended until April 30th and fewer than I thought converted.
Negatives of 10K:
Weren't unblinded on 12/31/2020....Unreal, IMO.
No Subsequent events info to glean
Change in language about Public announcement of data (anticipated)
No formal statement about being unblinded
No timelines for anything (just excuses due to covid)
"As also previously reported, coronavirus-related difficulties have impacted most aspects of the process, especially with the waves of COVID cases in many areas. The independent service firms have had limited capacity, and restrictions on operations. Key experts at certain specialized service providers have been unavailable for periods of time due to illness in their family. Other experts have gone on extended leave due to restrictions on operations. Clinical trial site personnel have been unavailable due to being reassigned for COVID, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples that are needed for certain analyses, and the firms conducting the analyses, continue to have only limited operations. Even logistical matters such as the shipping of materials have been, and continue to be, subjected to substantial restrictions and delays."
This is another change IMO, I believe this wording is different than before:
"This series of processes is under way. It is anticipated that public announcement will follow these processes."
I think that ship has sailed. LP could have done that (blackmail) in September 2020, IMO. I do not believe she could do it now without massive shareholder uprising and potential lawsuits. Shareholders will demand topline first. JMHO.
Article or PR?
Still, by law, they MUST hold an ASM this year
They also MUST release topline data...at some point.
While some warrants may expire, I doubt LP will let her (or other Mgmt) options expire. Nevertheless, right now, if all were options and warrants exercised we would be over the authorized shares.
So again, by my observations of LP's actions, the likely order will be ASM announcement of a date at least 6 weeks out. Proxy materials will go out with all the requisite required info along with voting items to include raising authorized shares.
I am confident that once that is done, topline will happen before ASM.
So, put these in order of completion, most are mandatory items:
1. They have to hold an ASM (and announce a date at least 6 weeks out)
2. They have to release topline data
3. They have to have more shares to supply outstanding options and warrants. (not mandatory as they could run out of time and shares if authorized shares not increased)
I believe they are in the correct order.