Replies to post #2329 on Spectrum Pharmaceutecals Inc (SPPI)

[AVII77]

do we have to wait till 24 months after the last patient is dosed before the data is mature enough to submit for approval? I don’t think so.

You are correct, we don't.

I've been (pleasantly) distracted recently with Amarin so I haven't been following SPPI as much as I should.

Regarding your point above, please consider the recent brigatinib approval.
Their primary study (for AA) was ALTA. Please see timeline info on page 242 here
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208772Orig1s000Admincorres.pdf
They planned their pre NDA meeting 2.6 months after the last patient was enrolled and planned their NDA submission 5 months after the last patient enrolled.

Other regulatory timelines for brigatinib are on pdf page 26 here
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208772Orig1s000MultidisciplineR.pdf

Do we have to wait for the secondary endpoints?

No

Now regarding the EU pts, do we have to wait for them to be recruited and EU patient data mature before we can submit the application?

I don't know. I'm thinking yes on them being recruited but no on waiting for their data to "mature" (see above).