Replies to post #188034 on Biotech Values

[DewDiligence]

No AH trading in OCRX (according to nasdaq.com), but I wouldn't be surprised to see a slight sell-off tomorrow due to the phase-2b enrollment delay.

[stuartscott8900]

Dew

Would you look to add to your position on a sell off tomorrow due to delay.

[rkrw]

Prior guidance was "mid" year.
But note this is the 2nd time they pushed out the timing.

[jq1234]

OCRX: I looked at ph2a data recently, had serious question regarding dose response from part A and B, asked the company but no explanation was given.

From part A, the first 24-hr dose was 5mg - see graph below - mean AL reduction was 34%. For part B, the first 24-hour dose was 10mg, mean AL reduction was <20% given mean baseline value were similar, 80 vs 78.7 umol/L. Higher dose here didn't result higher AL reduction, why would they expect better response with 20mg in ph2b trial?

From Feb 18 PR:

"Based on the pharmacokinetic data, we believe that a higher dose of OCR-002 will show an even greater ammonia lowering effect," stated Dr. Rajiv Patni, chief development officer of Ocera. "In Ocera's STOP-HE trial, designed to assess the safety and efficacy of OCR-002 in resolving neurocognitive symptoms of acute hepatic encephalopathy in cirrhotic patients with elevated ammonia, patients receive up to 20 grams per day of OCR-002, twice the dose administered to patients in this investigator-sponsored study. STOP-HE is ongoing and we look forward to a planned interim analysis in the near term."