Replies to post #631133 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

It’s been discussed here recently and probably before I’d guess. See below. However, Bio’s post today was really comprehensive and well layed out.

flipper44

Saturday, 06/24/2023 9:17:46 AM
flipper44
06/23/2023 10:24 PM
Post
# of 604268
FDA —
“Biologics have a considerably longer exclusivity period than small-molecule drugs. Biologic exclusivity conveys 12 years of total market protection (from time of approval), of which the first 4 years provide data exclusivity (no biosimilar application accepted by the FDA during that period relying on data obtained by the reference drug manufacturer). The purpose of the extended exclusivity for biologics is to promote innovation and continued development of these novel therapies, some of which can take years longer to develop than traditional small molecule drugs.”https://www.bu.edu/gdp/2021/05/25/chart-of-the-week-how-data-exclusivity-laws-impact-drug-prices/#:~:text=Data%20exclusivity%20operates%20independently%20of,not%20qualify%20for%20patent%20protection.

Data exclusivity is a form of intellectual property protection that applies specifically to data from pharmaceutical clinical trials. While innovator firms run their own clinical trials to gain marketing approval, generic manufacturers typically rely on the innovator’s clinical trials for the same approval. Data exclusivity rules keep generic firms from relying on that data for 5 to 12 years, depending on the specific law. Data exclusivity operates independently of patent protection and can block generic manufacturers from gaining marketing approval even if the patent has expired or the original pharmaceutical product does not qualify for patent protection. https://www.bu.edu/gdp/2021/05/25/chart-of-the-week-how-data-exclusivity-laws-impact-drug-prices/#:~:text=Data%20exclusivity%20operates%20independently%20of,not%20qualify%20for%20patent%20protection.

Under BPCIA, sponsors of new, licensed biological products approved through a BLA receive 12 years of “Reference Product Exclusivity.” (from approval) FDA cannot license any 351(k) application for a biosimilar or interchangeable product that relies on the previously approved product as a reference for biosimilarity during this 12-year period. This Reference Product Exclusivity does not attach to molecules that are the “same” as a molecule previously approved for the same sponsor.)

[biosectinvestor]

Thanks Senti. I vaguely referred to it here and there, referencing the affordable care act or FDA extension, but felt there was no need to go into the details given other protections and that the shorts were not going there much. But now, as we're starting to look commercial, shorts love to raise the IP arguments, so I thought it might be helpfull responding comprehensively. I've been doing a lot more DD in recent months and over the last year or so, I accumulate a lot of notes and then the details that just get lost by the sheer volume of stuff I'm focused on at the moment. But I have been going back over some of the research recently and reorganizing my past notes a bit. Last night lots of stuff just was popping up and made it easy to do a quick, comprehensive response to Ex.

Today's paper is incredible news. Very exciting new stuff to delve into.