NorthWest Biotherapeutics Inc (NWBO)

[iwasadiver]

How can people get such an easy concept so wrong that they make it a negative. It’s exhausting.

The whole purpose of the PIP is to make sure a drug company can show a plan for trials for the pediatric population while awaiting Marketing Authorization for adults. It does not stop the process of Marketing Authorization Approval to wait for results of pediatric trials. That would be crazy.

The MHRA has basically telegraphed they’re going to approve DCVax in my opinion. They certainly would not have issued a deferral to start the trials until after submitting an MAA if they were then going to hold up the adult process to get completed and analyzed pediatric trials done. That makes no logical or rational sense; “We’re going to allow you to submit the application but we’re then going to hold on to it for 2 years until you get pediatric trials done.” How can anyone even think this?