Replies to post #805876 on NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

I believe that you and Lykiri are generally in agreement. Also, I do agree with you that the DCVax-L approval and the Sawston facility MIA are both done and will be done under the new SI 87 framework, and the Sawston facility will be the control Hub for DCVax manufacturing.

I don’t believe Lykiri has said anything that would prevent compliance with SI 87. I don’t mean to speak for Lykiri, but what I believe Lykiri believes, is that the CHM committee does not itself issue a letter (CHM Letter) directly to NWBio, instead, the CHM informs the MHRA of its decision or opinion regarding the DCVax-L MAA.

Then, the MHRA informs NWBio of the CHM committee’s decision. Then, the MHRA will eventually send NWBio a Decision Letter (Grant / Refusal Letter).

But this letter is not a “28-day letter” that is issued when there are major objections or deficiencies. The Decision Letter will outline any conditions of the grant letter.

I don’t believe there are any major deficiencies or objections, so there is no need for a 28-day letter. I believe we are only waiting for the Decision / Grant Letter, which can come any day now.