Replies to post #307342 on $Rig's Platinum Penny Alerts

[rockman213]

Yes...great article. Must read for anyone looking into biotechs imo.
This ones a little older but very telling of where this one has potential to go.

So how big of a payday are we talking should Endonovo take the lead in ALF or NASH treatment? Depending on how you look at it, the opportunity could be huge with some estimates pegging the market at about $30 billion to $40 billion annually. New data from the American Liver Foundation estimates that about 30% of the US population is affected by NASH and other obesity-related ailments. Also, about 20% of the NASH cases will result in scarring of the liver and cirrhosis if left untreated, with the most severe cases requiring a liver transplant.

According to CEO Alan Collier, the complexities (cost, recovery time etc.) that go into procuring a liver transplant and the shortage of available donor livers are what makes the quest for a treatment for ALF and other liver diseases all the more important and potentially lucrative. While the race to treat rare liver diseases may not have many participants, this doesn't guarantee that firms pursuing treatments in this space will be automatic winners.

Intercept Pharmaceuticals (NASDAQ:ICPT) recently announced that it had concluded discussions with the FDA and EU regulators concerning phase III trials for obeticholic acid (OCA) in its treatment for NASH but the market was not too pleased with the proposed study.

Intercept's share price dropped more than 16% after announcing it would be conducting a 72-week interim study with about 2500 patients. The response came as no surprise since large trials push up the costs and more time will be needed to enroll patients which ultimately means that the date for submitting the drug to the FDA may need to be pushed back. Also, fears of OCA users trending towards higher LDL levels are a potential red flag. Regulators will be especially keen on monitoring this safety point which means that there is always a risk of Intercept being required to conduct a cardiovascular outcomes study.


Intercept shares decline on phase III study announcement (Source: Marketwatch.com)

On the other hand, Endonovo's conclusive pre-clinical studies, which you can read more about, have shown exceptional results in tissue and bone regeneration. Alan, CEO of Endonovo informed me that they believe the same mechanism that stimulated bone regeneration in rabbits and also expanded neuronal and blood stem cells to therapeutic levels in vitro also applies to other tissues and organs, including the liver. The firm is already going into animal studies to demonstrate this effect and create a final device for clinical trials.

But, what about Genfit's GFT-505 treatment? Well, the most recent results have proven to be a bit controversial. As Deutsche Bank analyst Alethia Young said at the release of the drug's study in late March, "Because the design was confounded, we find it very hard to draw conclusions based on the dataset". This was in reference to the fact that the study had missed its primary goal due to the fact that many of the patients in the study with early stages of NASH (about 15% of them) saw the condition clear up on its own.