I was long auxl and did pretty well. I didn't play any of the others. I believe the negative tone to pirf is related to the disease more than anything else.Also, it is asking a lot to complete two successful phase III trials where none have even come close. The shionogi trial was small and stopped early. Who is to say that had the trial gone to completion, it may have actually failed. My concern is growing by the day as I feel that the results are way over due. I actually was thinking that like appy, today would have been a good day to release results. The long weekend gave a chance to unblind and prepare the release. Oh well we will just have to keep waiting.
I think if one reviews the pirfenidone data carefully, you'll find that all studies, both large and small, phase II and III, have indicated efficacy in IPF. Others have shown possible activity in liver fibrosis.
The other interpretation of the Shionogi phase III data might be that they may have underestimated the actual theraputic effect because of the patients who dropped out of the placebo group.
Also, I would say that there have been drugs approved by FDA which have shown much less efficacy for diseases which are similarly lethal. How much time does a cancer patient with Erbitux? Months?
I think that any statistically significant protective effect as shwwn in the Shionogi phase III would suffice for a fatal disease which has no viable therapies to date. This is not RA - IPF patients die because they cannot breath or their hearts give out.
Lastly, do you really think the Japanese government would approve this drug - a first- in-class compound - if the Shionogi data wasn't compelling and the lack of alternative therapies?
I owned a medical technology company that needed F.D.A. clearance before we went " to market". We hired a consultant [formerly from the F.D.A.] to help us secure this. Our product was a non-invasive device and not a drug. We had extensive studies done on the efficacy of our product in England that I thought would facilitate the trip through the F.D.A. I was dead wrong! My consultant told me, and I quote, " the F.D.A. places zero value on anything done outside the U.S. and, in fact, has been known to make it more difficult on American companies in getting things approved if someone else did it first [like Japan]". They are elitist assholes--so if you are counting on Japan's actions being a positive here--prepare to be disappointed!