OncoJock: Reflecting on your posts today, AVC suggests:
- MAA filed by 6/30/23
- DOJ monitoring Cohen Milstein
- "On May 8, 2023, the Company received a $3.0 million prepayment for the purchase of securities for which the terms are in the process of being finalized." warrants consideration.
-
hoffmann6383
Re: OncoJock post# 592358
Thursday, May 11, 2023 7:56:00 AM
Post#
592362
of 592378
Oncojack, I disagree with nearly everything in this post. we will see submission within the next 90 days latest. There has been no delay. That is a baseless statement. It's always been a singular initial filing with additional applications to be filed strategically. reread the asm.
Bullish
BULLISHOncoJock:
OncoJock
Re: None
Wednesday, May 10, 2023 9:52:26 PM
Post#
592306
of 592373
Agree with Poor Man.
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.
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
Re: sentiment_stocks post# 592293
Thursday, May 11, 2023 7:40:02 AM
Post#
592358
of 592375
Agree with the first part of your post, about the logistics of patients needing to fly to the UK for treatment until after the MIA commercial license was granted on March 20. That's a very good point, and it's why we have these message boards, because n heads are better than one (in the words of the famous Norman Dalkey of the RAND Corporation). Perhaps specials and compassionate use revenue will finally begin to ramp up in the next quarterly earnings report.
However, after reading the language of this report, and seeing how very little work has actually been completed on the MHRA application, I am nowhere near as optimistic as you are with respect to timing of the submission of the complete application. I'm thinking end of this calendar year, at best.
Furthermore, let's also note the change, the reduction, in the number of applications being prepared. In December we were told during the annual meeting that multiple applications were being prepared for multiple regulatory authorities. LP explicitly used the plural form of the noun, as opposed to the singular. Now she is only using the singular, which IMO means she is not working on a simultaneous submission of any kind.
This will lead to further delays, most likely, for any approvals outside of the UK.
-- OJ
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