How do you know it will move forward if the parameters for success were not defined in the agreement? I think the company now knows the appropriate treatment window for multistem in stroke, ie less than 36 hours, but will Chugai move forward with the same agreement without statistical significance on the primary and secondary endpoints? Or will they have to come to come up with a different set of terms? Additionally, why would Japan allow conditional approval on an ad hoc analysis?
You are right, I am wrong. My source is completely off. The remaining derivatives reported by you are what I found in the SEC filings. Thanks for the correction.
What you say certainly makes sense to a degree. I'm just curious how the selection criteria, ie. those who don't improve within that window, might throw off your probabilities. It seems like you are modeling probability from studies that don't select from unimproved patients within the 24-48 hour window, which is required by this phase 2 trial.
What could the underlying conditions be for those who do not appear to recover well in the 24-48 hour window? Can you point to a study that identifies underlying conditions for stroke patients who don't improve within that window, but improve at a later stage?
In this case, the above citation is referring not to final approval, but to whether or not there are problems with the application that need to be addressed before the PDUFA review. The priority review begins 60 days after the filing review, if conditions are met for priority review.
The selling executives hold very little stock after each automatic sell. This isn't a thousand or so prearranged sales every quarter - they are large option plays. Why start the massive selling just six months prior to data release?
THe FDA SPA was granted before the breakthrough designation. Without the designation, you would be correct. The breakthrough designation changes everything however. The EMA might require the phase 3 though.
If confirmed, the company would likely need time to complete a NDA, then expedited approval from FDA. I really don't think a phase 3 would be necessarily breakthrough designation.
Does sevelamer restore ferritin, hemoglobin, etc levels? That is where the price justification comes in for auryxia. You are leaving out the costs associated with iron deficiency treatment, which sevelamer does not address. The difference matters when you are a dialysis provider given a set amount of money per patient to work with. See cost savings analyses that are readily available online.
Auryxia is in-licensed from Panion, with royalties set at mid-single digit payments. Japan sales are licensed out to JT Torii with royalty payments to KERX tiered to the mid teens. The ESRD market in the U.S. is around 400,000 and Keryx is charging $12,000 per year per patient. Do the math and you can see why we are priced over $1B right now. The EPS consensus estimates for 2018 are now at 1.99 per share. Apply a forward p/e of 20x and you can see how this is undervalued at the moment. Your comment about splitting revenues three ways is very misleading. If Auryxia observes sales of $500M in 2018, Panion would receive no more than $25M.
It truly is a wild guess at this point. My point is that some investors simply react to seeing EPS figures regardless of the underlying justifications. And right now those estimates are showing 1.14 per share for 2018. Obviously it could be much higher or lower in reality. These estimates are always fluid, but investors buy or sell on EPS estimates alone.
The 2017 EPS estimates are around .70. The 2018 estimates are now being posted with consensus at 1.14 per share. The 2018 estimates translate to $20 or so per share assuming a p/e of 20x.
Where is my commentary discussing this topic? And where is your commentary discussing anything of substance? You patrol this board like it is your job, but you never offer new insight. You must live a depressing life.
A good dose of healthy criticism is always warranted for any stock. There are pumpers as well as short and distort crews at work here. I think your question as it pertains to inflammation is a valid one.
With that said, I think multistem will stave off the cascade of events that leads to neuronal damage. I am not so sure there will be a latent mechanism that will allow a return of inflammation by day 90. If they arrest the cascade, what would be triggering a return of the inflammation? If we can presume it is effective at day 30, why would inflammation return by day 90 and why didn't it return by day 30? I just don't see any evidence that indicates a return to inflammation and reduced functional responses after day 30. I don't think the treatment for ischemic stroke should be compared to a chronic disease outcome. If there was an underlying disease for IS patients I might agree with you. But IS is an acute condition that leads to a secondary cascade. What formulation did you use to arrive at the conclusion that at least two doses are necessary? You are arguing that newly created neurons will degenerate before day 90 due to a return of inflammation. But what is triggering the return?