Replies to post #186493 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Flipper, do you think BP really cares much about the UK market?

Of the developed nations, they will negotiate the lowest price. The margin for BP will be, well, marginal.

I would think they make more (profits) in 1 year of product sales in the US than in lifetime product sales in the UK. That is one reason why most expensive drugs are first on market in the US. So yes, get it on the market on the US first.

Intentionally delaying the US and EU approvals by years to insure they have sufficient data for NICE is something BP would never do. Because they want to actually make money.

Besides which. Long term OS data does not require some magic time since last patient enrolled. It requires a sufficient mass of long term data.

IMO that data has existed for over a year. For better or worse.

[Lykiri]

For people who are interested, i found an EU study (more than 200 pg.):

Commercialisation of Advanced Therapies.

A Study of the EU Regulation on Advanced Therapy Medical Products
Faculty of Law University of Helsinki
Helsinki 2016

"The primary objective of this study is to analyse the benefits and limitations of the ATMP Regulation from the perspective of SMEs, academia and non-profit organisations that develop ATMPs. Secondly, it discusses the kind of amendment to the ATMP Regulation and related regulatory instruments and processes required to accelerate translation of research into advanced therapies and to facilitate commercialisation of ATMPs whilst ensuring the safety of patients. In addition, it analyses implications of the EU s limited mandate in the field of public health for developers of ATMPs. This study also investigates whether barriers to commercialisation relate to ATMPs as such or whether something else in the innovation system is impeding their market entry. As an example of potential ATMPs undergoing development, it also considers some specific, regulatory and moral patenting obstacles that impede the market entry of human embryonic stem cell-based products."
https://helda.helsinki.fi/bitstream/handle/10138/166228/Commerci.pdf?sequence=3&isAllowed=y

[joeycav11]

Perhaps NWBO does not trust FDA to approve so they want England and Nice approvoal first to ensure FDA is forced into quick approvoal