valuation model, page-16

db
my comment was related to the number of pts that have been 'on dose', which is an important part of regulatory safety requirements, and for ATC is about 450 I understand

that includes summing all the phi, ii and iii who started on 800 mg or were transitioned on to that dose

and is now well above the 300 or so expected by regulators fda/ema
see here http://www.ema.europa.eu/pdfs/human/ich/037595en.pdf

in other words with this number of pts and long-term use, AVX could file the safety component of the ATC NDA right now...

also to correct you, the phii numbers were about 50, and the phiii results to date are only from 2 of the 3 arms (800 and 3tc) and dont include the 1200 mg transitioned to 800 mg, so about 230-250 all up

with expanded acess programs only active in a few countries, I guess the question remains about how many phiii pts remain on ATC after trial ended...

and when we will here from the FDA approving an expanded access program allowing charging for ATC...look out for a rush of pts...and income...

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm177022.htm