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This suggests the PIP compliance check was completed about a month ago. For what then do they need the next 30-45 days?
"A UK PIP compliance check (CC) should be completed 60 days before your intended submission."
https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
Yikes, there is no 150-business day assessment. It's 150 all days. Oops
Maybe just a bookend for some imminent PR regarding combo trials, so that shorts can't contort those combo trial PR(s) into some admission by the company that they've moved on and given up on -L and decided not to pursue marketing approval for -L alone.
Maybe, but the 150-day assessment track counts all days not just business days. See: https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines
And they typically issue a decision in 80 days (all days) or less.
28-Sep + 80 days = 17-Dec
29-Sep + 80 days = 18-Dec
30-Sep + 80 days = 19-Dec
1-Oct + 80 days = 20-Dec
2-Oct + 80 days = 21-Dec
3-Oct + 80 days = 22-Dec
4-Oct + 80 days = 23-Dec
5-Oct + 80 days = 24-Dec
6-Oct + 80 days = 25-Dec
7-Oct + 80 days = 26-Dec
8-Oct + 80 days = 27-Dec
9-Oct + 80 days = 28-Dec
10-Oct + 80 days = 29-Dec
11-Oct + 80 days = 30-Dec
12-Oct + 80 days = 31-Dec
Yep, something pushed out this PR
typically <80 days under the 150-day assessment
28-Sep + 80 days = 17-Dec
29-Sep + 80 days = 18-Dec
30-Sep + 80 days = 19-Dec
1-Oct + 80 days = 20-Dec
2-Oct + 80 days = 21-Dec
3-Oct + 80 days = 22-Dec
4-Oct + 80 days = 23-Dec
5-Oct + 80 days = 24-Dec
6-Oct + 80 days = 25-Dec
7-Oct + 80 days = 26-Dec
8-Oct + 80 days = 27-Dec
9-Oct + 80 days = 28-Dec
10-Oct + 80 days = 29-Dec
11-Oct + 80 days = 30-Dec
12-Oct + 80 days = 31-Dec
Last post here 12/2/22
Who is Ned and what makes you think he'll be able to help with the volume?
I think someone on here noted that scotty turned into foogie
Some thoughts on Oncovir.
1. Hiltonol is Oncovir's branded, clinical-grade, stabilized formulation of poly ICLC (polyinosinic-polycytidylic acid). Although some trials disclose the use of Hiltonol, many trials appear to use poly ICLC from another source. Oncovir's patents appear to protect the clinical-grade, stabilized formulation of poly ICLC, but not poly ICLC itself. (The anticancer activity of poly ICLC was assessed as early as the 1970s (link))
2. Non clinical-grade poly ICLC is retailing through Sigma for $596/100 mg retail (link)
3. I don't know the exact amount of poly ICLC delivered to each patient in the P2 DCVax-L combo trial, but based other published clinical trial reports (link), the amount delivered to each patient over the course of treatment is less than about 5 mg.
4. Less than 5 mg of non clinical-grade poly ICLC bought in wholesale and/or bulk would cost substantially less than $30 per patient over the course of treatment. What is the premium for branded, clinical-grade poly ICLC purchased from Oncovir? The published supply agreements I could find redact the price paid, but even if it's 100X the cost of non-clinical grade, then that's still less than $3000/patient over the course of treatment. That's a little over 1% of the $250,000 cost of DCVax-L treatment.
5. If Tylenol worked synergistically with our vaccine, would we buy J&J, or just buy enough Tylenol to satisfy our needs? Or would we just buy unbranded acetaminophen from another source?
6. Hard to see the need and/or benefit of an acquisition of a company that produces a product that doesn’t cost very much (relative to DCVax-L treatment) and could just be purchased from them and/or sourced elsewhere. And further, if there is ultimately an approval based on poly ICLC+DCVax-L, what disadvantage would there be in just leaving the poly ICLC portion of the combo to a second prescription ordered by the patient’s care team for coadministration with DCVax-L?
7. To be clear, I am not saying that the combination of poly ICLC doesn't add value to the use of DCVax-L. I believe it's very clear that it does add tremendous value to NWs asset. I just don't clearly see the need and/or benefit in NW owning/supplying poly ICLC themselves.
Agree it would be different because here it just might be NW licensing the use of (and supplying for a fee?) it's not-yet-submitted-for-approval P3 asset to a BP so that the BP can assess its own (approved, or not-yet-unapproved, or approved-but-not-yet-approved-in-the-indication) drug in combination with NW's P3 asset.
And when they discussed their desire to do combo trials in the past that never happened did they have their P3 data and P2 poly ICLC combo data in hand?
Agree, but if the 10Q'd combo trial discussion(s) are consummated this quarter, and include a legitimizing partner(s) agreeing to an upfront payment(s), milestone payment(s), and/or future royalty payment(s), the re-valuation will begin even before the MHRA makes it's decision, especially if the new combo trial(s) are assessing efficacy in a cancer(s) other than GBM.
It's possible...
United States v. Tsai (2007): Benjamin Wey and Benjamin Tsai were convicted in a case involving stock manipulation, including spreading false information on message boards, to inflate stock prices of Chinese companies.
United States v. Smith (2009): William M. Smith Jr. was convicted for participating in a pump-and-dump scheme involving falsely positive information about a company on stock message boards.
United States v. Zirk de Maison (2011): Zirk de Maison was convicted for his role in a conspiracy that included posting false information on message boards to manipulate the price of a stock.
United States v. Bambenek (2012): Christopher Bambenek was convicted for his role in a scheme to manipulate stock prices by disseminating false information on stock message boards.
United States v. Fogarty (2012): John Fogarty was convicted for his involvement in a pump-and-dump scheme that used false information posted on message boards to artificially inflate stock prices.
United States v. Magna (2012): Jeffrey Magna was convicted for his participation in a scheme to manipulate stock prices through false information, including posts on stock message boards.
United States v. Pennings (2013): Joseph J. Pennings was convicted for his role in manipulating stock prices through various means, including posting false information on stock message boards.
SEC v. Falcone (2014): Vincent Falcone was convicted for engaging in a fraudulent scheme involving false information on message boards to manipulate stock prices.
SEC v. Vision Specialist Group (2016): The SEC charged individuals in a scheme involving false claims posted on message boards to inflate stock prices of a medical device company.
SEC v. Elgindy (2017): Anthony Elgindy was convicted for running a scheme that involved spreading false information about stocks, often on message boards, to profit from stock price declines.
SEC v. Kueber (2017): The SEC charged Joshua Kueber for manipulating the stock price of a company through false information, including posts on stock message boards.
United States v. Grenda (2018): Kevin Grenda was convicted for his involvement in a pump-and-dump scheme that utilized false information posted on stock message boards.
United States v. Tamayo (2019): Jesus Alejandro Tamayo was convicted for his role in a scheme to manipulate stock prices through false information spread on social media and stock message boards.
SEC v. Carver (2020): Timothy T. Carver was charged by the SEC for disseminating false information on stock message boards to manipulate the stock prices of multiple companies.
SEC v. Kluger (2020): Garrett Kluger was charged by the SEC for spreading false information on message boards as part of an alleged scheme to manipulate the stock price of a biotech company.
United States v. Leon (2020): Alan R. Leon was convicted for his participation in a conspiracy to manipulate stock prices by spreading false information, including on stock message boards.
SEC v. Jaspen Capital Partners Limited (2020): The SEC charged Jaspen Capital Partners Limited for manipulating stock prices through various means, including false information on message boards.
United States v. Wildberger (2021): Peter Wildberger was convicted for his involvement in a scheme to manipulate stock prices through various fraudulent tactics, including posting false information on stock message boards.
United States v. James (2021): Timothy James was convicted for his participation in a scheme involving posting false information on stock message boards to manipulate stock prices.
Does the SEC monitor private party litigation, and the evidence developed therein, in order to institute its own enforcement actions?
WorldCom (2002): Private lawsuits following WorldCom's collapse prompted an SEC investigation into the company's accounting irregularities.
Tyco International (2002): Private party litigation related to accounting fraud led to an SEC investigation into Tyco's practices.
HealthSouth Corporation (2003): Private litigation against HealthSouth executives for accounting fraud led the SEC to take action and pursue its own investigation.
AIG (2005): Shareholder lawsuits alleging improper accounting practices led the SEC to investigate AIG's financial reporting.
UnitedHealth Group (2006): Private party litigation over stock options practices prompted the SEC to launch an investigation into UnitedHealth's disclosures.
Mercury Interactive (2006): Private lawsuits alleging stock option backdating led to an SEC investigation into Mercury Interactive's financial statements.
Countrywide Financial Corporation (2008): Private litigation related to the subprime mortgage crisis drew the SEC's attention to potential securities law violations.
Bank of America/Merrill Lynch (2009): Shareholder lawsuits and private party litigation contributed to the SEC's investigation into alleged inadequate disclosures related to the merger.
Goldman Sachs (2010): Private litigation and public pressure prompted the SEC to investigate alleged fraudulent practices in mortgage-backed securities.
BP (2010): Private party litigation following the Deepwater Horizon oil spill led the SEC to investigate BP's risk disclosures.
Hewlett-Packard (2010): Shareholder litigation and allegations of improper conduct led the SEC to examine H-P's disclosures and practices.
Sino-Forest Corporation (2011): Private party litigation raised concerns about the accuracy of financial statements, prompting the SEC to launch an investigation.
JPMorgan Chase (2012): Private party litigation involving the "London Whale" trading scandal led to an SEC investigation into risk management practices.
Wells Fargo (2016): Shareholder lawsuits and private party litigation over the bank's unauthorized accounts scandal drew the SEC's attention.
21st Century Fox (2017): Private litigation related to sexual harassment allegations led to an SEC investigation into the adequacy of the company's disclosures.
Teva Pharmaceutical Industries (2018): Private party litigation over alleged bribery practices led to an SEC investigation into potential Foreign Corrupt Practices Act violations.
CBS Corporation (2018): Shareholder litigation and allegations of corporate governance issues prompted the SEC to investigate CBS's handling of sexual misconduct claims.
Facebook/Cambridge Analytica (2018): Private party litigation and media reports raised concerns about data privacy, leading the SEC to examine Facebook's disclosures.
Quad/Graphics (2019): Shareholder lawsuits alleging violations of the Foreign Corrupt Practices Act led to an SEC investigation into the printing company's operations.
That's right, after 15 years why would the quit now that they have an approvable, partnerable, licenseable, combinable, manufacturable asset?
Hmmm. Spoofing was illegal before NWs complaint as filed. So they weren't supposed to be doing it even before the complaint was filed. But they did anyway. So why would they stop when the complaint was filed? It didn't become more illegal when the complaint was filed. So yes, 'one would think' they'd stop when they were shown they weren't being watched. Ya know, unless their CBA said it was lucrative, and any future penalty would be less than the ill-gotten gains. Although the enforcement landscape seems to be shifting in a way that might also shift their CBA.
If you think we were having 'a conversation', then you should actually read the link I posted so you can see that your response to it had nothing to do with it. But you know that. It is not spoofing/illegal to sell/buy shares. It is spoofing/illegal to pretend that you are about to buy/sell shares for the purpose of manipulating the price of those shares.
It's a civil action so if one or more of the defendants is found liable, monetary damages only. SEC/DOJ could institute their own criminal proceedings at their discretion at any time, depending what evidence they have, or from what evidence is developed through the civil action. They already have access to NWs civil complaint.
Full list of awardees includes Autolomous
https://www.ukri.org/news/13-million-to-help-transform-medicines-manufacturing/
Beartrap, to your point, the P2 polyICLC combo trial (NCT01204684) set out to enroll 60 patients, with the goal of measuring "Time to tumor progression and overall survival" over a 2-year period.
In January 2015, the Overall Status was changed from Recruiting -> Active, Not Recruiting. So if they stopped Recruiting in 2015, and they intended to follow patients for a 2-year period after treatment, why is the Primary Completion Date listed as January 2024 (i.e, 5 months from now)? It would seem the planned 2-year follow-up from the last recruited patient would've been completed no later than sometime in 2018. Or are they waiting for the OS tail to mature beyond the 2-year follow-up?
They'd be beyond 5 years from final patient recruitment at this point.
Outline
https://www.thesaurus.com/browse/outline
Relevant synonyms
"I am not hiding and I don’t believe anyone else is. We are working to complete the [[blueprint, framework, summary, synopsis, lay out]] discussed at the beginning of the yr and updated in the most recent Q."
Dave
Clearly when he said that the US-based trial docs are ready and waiting to use dcv, what he meant was that they are ready, waiting and will shortly be moving to the UK, Germany or Canada so that they can use dcv....
That page was created in 2003
He has his background blurred this time.
I believe it'll be the other way around. I believe we'll see partnership(s) first, just before or around MAA submission.
On 11/8/22 in their 10Q, NWBO stated that the company "is currently considering possibilities for legal actions against third parties who have attacked the Company." On 12/1/22, NWBO filed a lawsuit against eight marker makers.
On 8/9/23 in their 10Q, NWBO stated that the company is "in active discussions in regard to certain combination treatment regimens, and is planning for certain strategic trials with such combination treatments." On [tick-tock], NWBO PR'd the details of the first of these combination treatment trial partnerships.
8/25 i believe
Actually I think he wasn't referring to skeptics, but to disingenuous, twisted words bullshit posts like your post right here.
By masterpiece do you mean just enough to keep longs in their position, while also not enough for the shorts to yet exit theirs?
There is more than one possible combination that can be trialed. Maybe it's the same combo as the one that you reference, but in a different cancer type. Maybe it's a P3 of the one you mention because that's not a P3. Maybe it's a combo of DCVax-L with some other therapeutic that we haven't seen combined with DCVax-L already. There are lots of possibilities. Will know soon which one some other party wants to try next.
Right, and then you stopped right there. Keep digging.
Where'd you look? Or are you trying to get Flipper to your dd for you?
So how much of this delay in filing is from waiting for Eden to be ready
Gain Contingency
"Between May and June 2023, the Company entered into certain non-dilutive funding agreements with multiple investors, pursuant to which the Company received funding of $4.1 million related to a gain contingency."
Thoughts?
"What is a Gain Contingency? A gain contingency is an uncertain situation that will be resolved in the future, possibly resulting in a gain. The accounting standards do not allow the recognition of a gain contingency prior to settlement of the underlying event."
Some things I would like to hear more about from the company
1. Marketing application(s)
(Preparation status, Target countries, Regulatory pathway(s), Target submission date(s)/acceptance date(s), Target RA decision date(s))
2. Manufacturing
(Current monthly DCVax-L capacity, 12-month target monthly DCVax-L capacity, CRL, Eden, Autolomous)
3. Specials
(Number treated (monthly, trailing 12 months; 12-month target), Revenue realized (monthly, trailing 12 months; 12-month target))
4. Uplisting
(Target exchange, Target date, Protocol/process/timing)
5. Cash
(C shares available/placed, Common shares available/placed, Institutional investors)
6. DCVax-L GBM
(Trial(s), PIP (Target start date, Target end date, Partner(s)), Combos (Target start date, Target end date, Partner(s)))
7. DCVax-L non-GBM cancers
(Trial(s), Partner(s), Combo(s), Basket(s), Agnostic marketing application(s))
8. DCVax-D
(Trial(s), Partner(s), Combo(s), Basket(s), Agnostic marketing application(s))
The deadline for a Large Accelerated Filer is August 9th.
The deadline for an Accelerated Filer is August 14th.
"A Large Accelerated Filer has a public float of $700 million or more, as of the last business day of the issuer’s most recently completed second fiscal quarter." https://www.sec.gov/corpfin/secg-accelerated-filer-and-large-accelerated-filer-definitions