Biotech Values

[srsmgja]

<<BAP is never going to get approved. I sat in on the BAP presentation at AAN around a month ago. There were over 10 cases of vasogenic edema in their phase II trial, and the worst part its not dose dependent>>


Here is the actual summary of Vasogenic edema in the phase 2 trial

- 12 patients with vasogenic edema

- 10 were in Apo carrier, 2 in non-carrier

2.0 dose ( 6 carrier, 2 non-carrier)

1.0 dose ( 3 carrier)

0.5 dose ( 0 )

0.15 dose ( 1 carrier )


- All cases resolved over weeks

- Only 1 patient treated with steriods for lethargy and some mild confusion

- 6 out of 12 were re dosed after resolution. In no case was were any recurrence of the vasogenic edema.





Just to remind everyone, in the phase III trials, there is only one dose for the carriers and that is the 0.5 dose.


There were 3 doses for the non-carriers ( 0.5, 1.0, and 2.0)


Elan/Wye stopped the 2.0 dose aprrox. 3 months ago because of the monitoring committee noted a rate of vasogenic edema above a pre-specified level in that ONE COHORT. At the same time, ALL of the other dose cohorts were looked at, and were BELOW pre-specified limits.