Recriter43- science is good. They need a lic agreement and/or fda news and we should be good to go. I don't see them doing a secondary at this level and I do not see them going broke.. Something will happen. It is just a matter of time. As far as the competition, there is plenty of room for cnat and others a s well.- look at all of the anti-depressants on the market as well as statins and dementia drugs to site a few- jmo,
GNFT is further along and seems to be as good a bet as CNAT. CNAT is positioned now (in price and study time line) where GNFT was in 2014. I see a tremendous upside potential for both companies. (There is not just one way to approach a problem and/or a disease entity).
I have very limited hopes for ICPT to go anywhere but down. Too little of a market for biliary cirrhosis- and the burn rate they will experience in trying to disprove what appears to be a failing drug in it's early clinical trials has left me asking why they just don't stop here and deal with the narrow market where they have shown result?
The higher dosage has accompanying life-threatening risks- seems like a recipe for a non-approval to me.
Seeking Alpha Article:
Intercept was granted conditional market approval for Ocaliva, its flagship drug, in the PBC indication.
However, the biotech’s main target market remains a much larger indication, NASH, for which Ocaliva is currently in a pivotal Phase 3 trial.
With Ocaliva’s official label released, how can investors interpret the impact of current limitations on the drug’s NASH prospect?
With conditional market approval granted to Intercept's (NASDAQ:ICPT) Ocaliva in primary biliary cholangitis (PBC) patients, the drug's official labelhas finally been issued, reflecting the FDA's opinion on Ocaliva's risk / benefit balance for this indication. While this event was widely anticipated following aunanimous backing by the agency's advisory panel, the interesting news here lies within the details of this approval: Ocaliva was indeed approved to treat refractory PBC patients (in combination with ursodeoxycholic acid, or UDCA, or as a monotherapy in some cases) but under very specific limitations. Here are selected extracts of the announcement:
NEW YORK, May 27, 2016 (GLOBE NEWSWIRE) - Intercept Pharmaceuticals, Inc. , a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis, previously known as primary biliary cirrhosis (PBC), in combination with ursodeoxycholic (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
This indication is approved under accelerated approval based on a reduction in alkaline phosphatase (ALP). An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Based on ICPT approval- which is limited and only because the drug dropped one blood value (alk phos in serum- a measure of liver and biliary function)- seems to me there would be an easier and quicker approval (along with being more encompassing and less limited) for CNAT. The ICPT product was on fast track as well and they did complete a phase III- however, the FDA has already indicated that a phase IIb or phase III might lead to an early approval for CNAT. I still believe that CNAT is meeting now with the FDA. (I called IR and was informed that they will not publicize and/or announce any meeting with regulatory authorities.) I still feel that an announcement will be forthcoming of a short targeted trial with the goal to be for a quick approval here within the year in a focused population.
I further for the life of me cannot see why ICPT stock price is where it is at (they were as high as $462/share)
They have only one product- just recently approved- which does not seem like it will produce much income compared to what they anticipate burning through.