Replies to post #418277 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

No, that language was from BEFORE they locked and got carried forward as a kind of risk factor by their counsel in drafting their disclosure documents. There were delays likely during the early pandemic previous to their data locking, and those delays never go away once incurred.

Here it is in the 2nd Quarter, as of March 2020 Quarterly Report. Lawyers put that language in to cover risks and issues that MAY have happened to delay the locking of the data at that time, and that might be an issue going forward for investors who might complain that "everything is taking too long". When the data lock was delayed, that is also an ongoing delay. If you got delayed for x months, then that delay carries over as a delay on an ongoing basis. The delay is not over because NOW you've locked. You were delayed so you're still delayed.

It is not exactly the same, but says basically the same and it gets modified going forward in all further filings, likely as per the advice and drafting services of their legal counsel and to address circumstances that may have happened, in fact, that delayed them. Those delays may also have caused those firms difficulties in performing, so referencing a risk like that would cover that contingency. Doesn't mean it happened exactly as described, it means it's a potential risk that someone wants to be sure they covered in all its potential dimensions. Lawyers over draft on such things regularly. But that is how they earn their keep.

https://www.sec.gov/Archives/edgar/data/0001072379/000110465920076154/tm2014603-1_10q.htm

As also previously reported, coronavirus-related difficulties have impacted most aspects of the process. Trial site personnel have been unavailable due to being reassigned to COVID-19 patient treatments or otherwise, and the limited site personnel have had to work under restrictions. Committee processes such as Institutional Review Boards and Ethics Committees have been, and continue to be, focused mainly on COVID-19 matters, with other matters significantly delayed. Regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples needed for certain final data, and the firms conducting the analytics for that final data (such as IDH mutation status), continue to have only limited operations. Even logistical matters such as the shipping of tissue slides have been, and continue to be, subjected to substantial restrictions and delays.

Here is a variation in the August 2020 10Q:

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000110465920092797/nwbo-20200630x10q.htm

As also previously reported, coronavirus-related difficulties have impacted most aspects of the process, especially with the resurgence 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 to COVID-19 patient treatments or otherwise, and the limited site personnel have had to work under restrictions. Committee processes such as Institutional Review Boards and Ethics Committees have been focused mainly on COVID-19 matters, with other matters significantly delayed. Regulatory processes have been similarly focused on COVID-19 matters and delayed on other matters. Firms such as the ones storing the Phase III trial tissue samples needed for certain final data, and the firms conducting the analytics for that final data (such as IDH mutation status), continue to have only limited operations. Even logistical matters such as the shipping of tissue slides have been, and continue to be, subjected to substantial restrictions and delays. However, the CRO and the Company are working intensively with these vendors on a continuous basis to move as quickly as possible.

And from the current 10Q, it looks like it was kept in an effort to maintain an abundance of caution, by counsel or whomever, in an ongoing concern section. Let's see it in the full context:

2. Financial Condition, Going Concern and Management Plans

https://www.sec.gov/ix?doc=/Archives/edgar/data/1072379/000110465921139211/nwbo-20210930x10q.htm

The Company has incurred annual net operating losses since its inception. The Company had a net income of $45.8 million for the nine months ended September 30, 2021. The Company had a net loss of $47.7 million for the nine months ended September 30, 2021 after removing the non-cash derivative gain. The Company used approximately $27.1 million of cash in its operating activities during the nine months ended September 30, 2021.

The Company does not expect to generate material revenue in the near future from the sale of products and is subject to all of the risks and uncertainties that are typically faced by biotechnology companies that devote substantially all of their efforts to research and development (“R&D”) and clinical trials and do not yet have commercial products. The Company expects to continue incurring annual losses for the foreseeable future. The Company’s existing liquidity is not sufficient to fund its operations, anticipated capital expenditures, working capital and other financing requirements until the Company reaches significant revenues. Until that time, the Company will need to obtain additional equity and/or debt financing, especially if the Company experiences downturns in its business that are more severe or longer than anticipated, or if the Company experiences significant increases in expense levels resulting from being a publicly-traded company or from expansion of operations. If the Company attempts to obtain additional equity or debt financing, the Company cannot assume that such financing will be available to the Company on favorable terms, or at all.

Because of recurring operating losses and operating cash flow deficits, there is substantial doubt about the Company’s ability to continue as a going concern within one year from the date of this filing. The condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets, or the amounts and classification of liabilities that may result from the outcome of this uncertainty.

As previously reported, coronavirus-related difficulties have impacted most aspects of the database lock and the process of analyzing the Phase III trial results, especially with the successive waves of COVID-19 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 sites have not allowed personnel from the contract research organization managing the trial, or other service providers, to visit the sites for trial matters such as data monitoring and collection activities. Clinical trial site personnel have been unavailable due to being reassigned for COVID-19, and the limited site personnel have had to work under restrictions. Committee processes and regulatory processes have been similarly focused on COVID-19 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 have had only limited operations. Even logistical matters such as the shipping of materials have been subjected to substantial restrictions and delays.

And then they actually locked on October 5th, 2020:

https://nwbio.com/northwest-biotherapeutics-announces-data-lock-of-phase-iii-trial/