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flipper44

09/14/23 1:40 PM

#630940 RE: Dr Bala #630916

DCVax-l is protected by more than orphan status exclusive use (10 years from first approval)

It is also protected by exclusive data use. Nobody else can use the phase iii trial data (long term safety and efficacy) to support any attempts at biosimilars for about a decade.

Not to mention DCVax-Direct which has patent protection on the latest improvement/version until about 2036 perhaps 2037.

Not to mention countless Flaskwork process patents for closed system automated manufacturing of DCVax products. Most of these are good beyond 2037.