Replies to post #769236 on NorthWest Biotherapeutics Inc (NWBO)

[meirluc]

MAA approval by June 30 is certainly a possibility because:

"MHRA began the consultation on International Clinical Trials Day. The agency and UK government used the day to highlight work to create a faster, more effective clinical trials system, notably the move to a new regulatory framework that began last month."

So these consultations are very likely aimed at creating guidelines with many other regulators concerning the legitimacy
of the employment of external controls in upcoming clinical trials and that is based on MHRA's validation of the
use of external controls in the DCVax-L trial. MHRA simply used the International Clinical Trials Day as a convenient
consultation deadline that will likely follow the MAA approval.

Clearly, the consultation request to other regulators is not an MHRA attempt to legitimize its consideration for
the approval of DCVax-L. It is instead a pathway to legitimize future trials that may have to utilize external controls
in lieu of placebo arms and that legitimization would be based on the proven success of the DCVax-L trial.

[color=red]]Does anyone still doubt that this is not a superb piece of evidence that the MHRA intends to approve the MAA
very soon?[/color]

[Investor082]

Agreed. I have said this ever since their report came out around end of March which linked non attendance of ASCO to back and forth with MHRA.

Lykiri was still pumping end of May approval. He will be exposed in a week.