It is possible. There does not have to be an SPA for approval. TGTX is arguing that Imbruvica, Zydelig and Venclexta were all approved on response data from single-arm studies and no SPA, so a positive benefit in Genuine under the same terms ought to achieve the same result.
If an amended and FDA approved SPA currently exists, on what terms?
TGTX is being sued by several law firms. I know these law firms are ambulance chasers, but they at least need to state a reason to file a lawsuit. Their stated reason is because the SPA was invalidated.
News 
Market Data 
Discover 
