Interesting info, thanks. I checked the original protocol (fda.gov). The steroid was IN it, to start with. If someone did not get it than that was a protocol violation, and should not be evaluated for safety. However, I could not find any controlled study documenting that steroids reduce chemical arachnoiditis. Did DepoTech present scientific EVIDENCE of efficacy of steroids?
- I did not find relevant info on Mr. Longenecker, so I don't know. You probably know much more. However, he has always been there as COO overseeing the preparation of the DepoCyt NDA, hasn't he? Wasn't he the "real" boss? Let me know.
- You wrote that DepoTech, with an oncologist medical director, founder and board member, who signed off on the NDA, blame Ms. Paradiso for medical incompetence? The receptionist or the CFO should also be blamed, shouldn't they. I don't buy this. It's like hanging the gunners for Waterloo. Paradiso is a DVM, so how would she know? Wasn't it DepoTech's and Chiron's medical directors and investigator MDs who reviewed and/or presented the data?
- Agree on the captain analogy.
Regards,
StockDoc |
