Thursday, November 03, 2016 2:18:51 PM
Yesterday's PR stated 3 or 4 important concepts I would like to highlight:
1) The different dosing in the ENCORE PHph2b trial (they have added the max dosing of 50mg twice daily). That is double than the 25mg dossage used so far in the LC trials, we could see improvement in efficacy vs the ph2a (just 28 days) and vs the LC trial (6 months but at 25 mg). Bearing in mind that the 25mg dosage for 28 days already has given a stat sig reduction in Portal Pressure for the same Severe Portal Pressure population
2) There is a hint in the PR that, since the trial is using approvable endpoint(s), depending on efficacy and safety results, despite being a ph2b and not ph3 , may warrant accellerated approval
3) There is a hint in the PR that, after NASH Cirrhosis approval , a label expansion (to other Cirrhosis etiologies) will be implemented.
To summarize this trial, may prove Emricasan as very effecting at reducing HPVG, grant the basis for an early approval and a subsequent label expansion.
Let us not forget that ca 50M globally suffer from LC, and that 1.2M people died of LC in 2014. If the treatment is safe and effective for chronic administration as it has been proved so far, I would think AT LEAST 1M of the (50M and growing) LC patients would use Emricasan, possibly more if it can save as avg 1.2M lives each year. The price tag would be at least $70K per annum per patient (as ICPT drug for primary biliary cirrhosis). That would be equivalent to $70B revenue per annum or $350B in market cap, or 10,000 times current PPS. I am amazed how this company, with $25M in cash on hand, no debt and IP protection until 2028, could trade just above $30M
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