two generics widely prescribed for fissures, they mix it together and the trial goes kaboom.
I pretty much thought this was a slam dunk, I didn't have that big a position considering this was nothing more than a generic combo that wouldn't have a huge market, but wasn't expecting it to be no better than nothing.
" a primary purpose of this second Phase 3 trial was to complete the safety data package for a New Drug Application (NDA) with the FDA" It met safety and efficacy. I think it will still get approved. Let's say a patient is in the Doctor's office for a problem and the Doctor looks and says to him/herself, it doesn't look too bad, but the patient is insisting on getting some medicine, I will prescribe Diltiazem cream, it's harmless and patient will get better with or without it. (If it's not too expensive).
It had an abnormally high placebo effect thus showing no difference between drug-placebo. The drug worked similarly as in the first trial. For some reason placebo group showed a much higher benefit than before. Interesting position to be in as FDA may approve anyway since it is still safer than the compounded version and has 1 great trial and one odd trial with similar result on drug side.