Avid Bioservices Inc (CDMO)

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1st Look-in Projections Updated

This new update takes into account:

- Complete Enrollment by end of January (instead of end of December 2015)
- Dropped-outs Statisitics also considered (censored patients Chart provided by Mojojojo )
- 1st lookin happens on 1/3 of 80% eventing (155 events) as per RRdog # 251028
- Eventings distribution follows Herbst´s trial (already considered in last update). Placebo arm 9.9 MOS



According to the assumptions taken for the calculations (see also below), 1st Look-in would happen:
- For a 13 MOS Bavi Arm: 2nd half February
- For a 15 MOS Bavi Arm: 1st half March
- For a 17 MOS Bavi Arm: 2nd half March

ASSUMPTIONS:

Enrollment (Golfho's model updated)



Eventinsg Distributions per Case: (based on Herbst trial results)







Herbst´s Trial (for assumed eventing monthly distribution)




For Censored Patients / Dropped Outs data (thanks to Mojojojo)

Early dropped outs insignificant (see red arrows)