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Wednesday, May 10, 2023 9:52:26 PM
This 10-Q paints a picture of a company with very poor liquidity, and poverty is a weak position from which to negotiate with Big Pharma.
Vendors and lenders are being paid with shares of stock.
Series C preferred shares are being issued to pay the bills.
Actual sales revenue is minimal, only $800K over 3 months, despite what we've been told is high demand for specials and compassionate use doses produced at Sawston. Yet the cost to run the company during the same period was $13.8 million.
And, judging by language in the report, we are still a long way from even submitting the MAA application, much less having it deemed acceptable by the MHRA. Here are some passages, with page references, that show we have months to wait, if not longer:
Page 8:
The Company . . . . is working on prerequisites and preparations for filing an application for regulatory approval of the product.
Page 17: Chart showing research and development costs paid to Advent during the quarter makes it clear there are are 6 one-time milestones associated with completing the application for regulatory approval (not counting drafting the actual application which presumably would be a 7th project), and that the milestone for drafting key portions of the application for product approval had not been completed by March 31.
Page 17, cont'd. Footnote (3) in the chart makes clear that only one of 6 projects related to the application, the project describing the mechanism of action of DCVax, had been completed as of March 31. The other 5, namely sections on comparability, stability, potency, product profile, and fill/finish, remained to be completed.
![](http://investorshub.advfn.com/uimage/uploads/2023/5/10/gdrkgchart_on_page_17.png)
Page 23:
The Company is now working on preparations for an application for regulatory approval of DCVax-L. The Company is working with teams of specialized consultants on pre-requisites for the application, and on portions of the application package itself.
Putting this all together, it's abundantly clear to me that 1) the MAA application has NOT yet been submitted to the MHRA, and 2) at this pace, it could easily take the rest of this calendar year before the application is ready for submission.
Which makes me wonder: are they going to delay the annual meeting again this year until after the application has been submitted and accepted by the MHRA? If so, it could very easily be delayed until November or December again.
-- OJ
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