NorthWest Biotherapeutics Inc (NWBO)

[MI Dendream]

Early access programs are only granted to products that gave demonstrated sufficient evidence of benefit and safety to warrant early use as part of a broader safety registry before an American and/or EMEA marketing approval which is separate from specials and the like. EAPs require regulatory approval only after certain stage criteria are met.

Our Operations under early access programs may not be successful.

There is not much accumulated or available experience, information or precedents in regard to early access programs, especially for new types of treatments such as immune therapies. Establishing operations under an early access program will require us to establish and implement new operational, contractual, financial and other arrangements with physicians, hospitals, patients and others. We may not be successful in establishing and implementing such arrangements, and/or such arrangements may not be financially satisfactory or viable.

That last bit is important as there are lots of services required in the US that would not be covered by insurance and are cost prohibitive without a sales force and patient services department providing assistance which is paid for through profits received manufacturing and selling the drug. Without the profits, there is no money for storage and lymphopherisis and accompanying services otherwise not required for SOC.