NWBO did everything necessary to obtain a commercialization license for adults for DCVax, if the MHRA approves the data. Period. The PIP allows them to explore the therapy in children.
Its funny how the narrative changes from month to month. It started with "no peer-review", we got that in JAMA. Then it was there would never be a submitted marketing app...we got that. Now we get "they arent running pediatric trials" so it wont be approved. Do you know how absurd this is?
Here is a tidbit for you:
"In the United Kingdom, drug companies typically need to run pediatric trials when seeking approval for a new drug if the medication is intended for use in children or if it could potentially be used in pediatric populations. This requirement stems from the European Pediatric Regulation, which mandates that drug developers conduct studies in children as part of the drug development process.
Specifically, pediatric trials are required when the drug is intended for:
1) Treatment of pediatric diseases or conditions: If the drug is intended to treat diseases or conditions that primarily affect children, pediatric trials are usually necessary to establish safety, efficacy, and appropriate dosing in pediatric populations.
2) Off-label use in children: Even if a drug is primarily developed and approved for use in adults, if it's anticipated that healthcare providers might prescribe it to children (off-label use), pediatric trials may be required to assess safety and effectiveness in that population.
The goal of requiring pediatric trials is to ensure that medications used in children are thoroughly evaluated for safety and efficacy, as children may respond differently to drugs compared to adults. This regulation aims to promote the development of safe and effective medicines for pediatric populations."
The fact is NW doesnt even need to run P trials if they never intent to use it in children, but the market is much larger with children included. Glad they got a approved PIP.
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