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Thursday, January 18, 2018 1:45:43 PM
Besides, reading the PR that was contained in the lawsuit Avii linked shows what they PR'd. They PR'd they've been granted a "Swiss But the PR indicated that DCVax-Brain had been granted a “Swiss ‘Authorization for Use’” to “make it commercially available for treatment”.
However, then as pgsd cited, the passage from the 10K indicated the authorization for use was conditional upon certain commitments that had to be fulfilled to the satisfaction of Swissmedic - before the company could actually make it available (like finalizing their clean room suites), which probably seemed like a no-brainer ... at the time. The company even indicated that they felt they very quickly had fulfilled those commitments. Of course, experience has now shown (rather thoroughly - Swiss, German, UK) that these special approvals end up being granted with a lot of strings attached.
Then during that time that they were fulfilling those "certain commitments" (about 3 months), BAG (who’d granted the authorization for use) and Swissmedic underwent reorganization. The authorization was then transferred to Swissmedic. At that point, Swissmedic wanted all of those companies who had received one of these types of authorizations to then file a Marketing Authorization Application (MAA) with them. Which, keep in mind, the company did at the end of 2007 (they were granted the authorization for use mid 2007).
Swissmedic then took TWO years to conduct inspections and evaluate and reevaluate this MAA. And, according to the 10K, the manufacturer they were working with to work with Swissmedic stopped working Switzerland which threw the entire operation into a further tailspin… to the point that it seems the company decided to walk away from this seeming road to nowhere rather than keep chasing it.
There was no lie, IMO. DCVax was indeed granted a Swiss Authorization for Use, and that should have led to a marketing authorization. And that is what the company had PR'd.
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