Soligenix Inc (SNGX)

[dewophile]

orbec safety in 10 day "run-in" period

when the ph 3 was first published, I and some others discussed the first point you raise, namely did the higher failure rate in the orbec arm during the first 10 days signal some safety issue with the drug when given concurrently with prednisone. a few comments:

1. this did not occur in the ph 2 as wel all know
2. there is no physiological rationale for how orbec could possibly have a negative interaction with prednisone
3. the heterogeneity of the population in general speaks to the fact that the FAR more likely explanation is an imbalance in the arms to account for the higher failure rate
4. the FDA has never signaled a concern related to orbec's safety (and my private communication iwth the company as confirmed that the FDA is not raising safety concerns at all - the entire issue is resting on efficacy at this point)