Replies to post #684971 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

So when Lappin was trying to sell tens of millions of dollars in Specials revenue the first year, do you think she was just confused?

[Smitty5150]

To enter in the Specials Program the MHRA requires: "patient access eligibility, product license status, regulatory process and timelines to initiate, costs, scientific assessment by the MHRA, ability to collect real world data/evidence, and involvement of other national bodies including the National Institute for Health and Care Excellence."

Furthermore: "First, the PIM "Specials" application can be made when early clinical data indicate the medicinal product meets the designation criteria, by demonstrating significant potential benefit for patients with life-threatening or seriously debilitating conditions with high unmet need."



What you posted is very misleading....what you are trying to make people believe is: that the UK would let anyone start a Bio Company, make a drug without ANY proof of efficacy or its info safety profile, apply for specials access, gain acceptance without any evidence, and let the Company sell it to people who pay out of their own pocket without ANY regulatory oversight outside of manufacturing. Thats not the way it works. The UK MHRA is HIGHLY involved with PIM and helping companies navigate the clinical data and related applications that may lead to approval. Stop with the BS.