ImetelChat

I wonder if the two FDA “no” votes realize what a miracle that is.

CKTC’s theory about why the FDA came out with guns blazing is interesting. With all of the handcuffs placed on docs these days (read “you need prior authorization for that”) the fight to let doctors be doctors is valid and valuable. We hate being directed by others who have never even seen a patient...

Great point, the FDA sets a statistical bar, it is met, but once it is, it’s still not enough? Thank G-d statisticians don’t treat patients. I am still stuck on the brew ha ha over the absence of CR’s and PR’s. Maybe someone can help me here. If LR patients have < 5% blasts, how does one assess a PR...

I raise my glass to Fish Sr.and Irish. Wish they could be here to help us celebrate. And of course to John and his team who had the vision to see this through to this point. And to all who have contributed to making this board worthwhile. My thanks and admiration. bp

Who was the second no vote?

Just got home after important family obligation. Obviously a lot has happened but was able to intermittently tune in. Geron hit it out of the park. Great presentations all around. Masterful, informed, confident. I was struck by a couple of things besides what has been discussed here today. Did I und...

KT, well tomorrow is a seminal event for sure. My thanks to everyone who has contributed to furthering our understanding of this drug and the studies that support it (or don’t), guess its who you ask…:)

Well, if the 2018 guidelines are used the results look stellar and include a strong endorsement for HI. If this end point is excluded by using earlier, older guidelines we still have 1. Primary endpoint reached. 2. Key secondary endpoint reached. 3. Caveats re cytopenias etc. Points 1 and 2 are fact...

Yup, I think you have hit on an important point. The first patient was enrolled in 2015 in part 1, obviously before the 2018 criterion were adopted. Will the FDA require the 2006 criterion to obtain because of that? We are talking about a study start to top line (not yet even at final completion dat...

First off, your posts have been incredible and really helped to make sense of a what amounts to a very surprising FDA position paper. I can understand that the FDA would want to look at the negatives carefully. In this case however using criterion for HI that are almost 20 year old and are no longer...

Right you are. Geron is going to have to tread carefully not to irritate the FDA which as you point out used IWG criterion that are almost 20 years old and have been updated at least twice since then. Also the astounding HI rates in the placebo group, well, I tried to find confirmation. Just not sur...

Presenting for Geron at FDA Thursday. Impressive.

KT pretty strong line up on the Geron side:

https://www.fda.gov/media/176961/download

As to Dr. Hunter, pretty sure he is well aware of the limitations of present day treatments.

KT, yes the panel will look at everyone in the study including non responders. Right now I am looking at this as the FDA is evaluating a study that they approved and evaluated on a rolling schedule. The study met its primary end point with a strong P value. The study met a key secondary end point wi...

Here’s the FDA doc:

https://www.fda.gov/media/176966/download

I have to agree. Hematologic improvement (a reduction of 4 units every eight weeks) still amounts to a lot of transfusions saved. Having a very high bar to assess actual benefit makes the choices clear. A personal anecdote: When I started catheter based treatment for A-fib almost 20 years ago, the b...

I was blessed to have Hy Zimmerman as a GI professor when I was in med school. A key component to Hy’s law is “ No other reason can be found to explain the combination of increased aminotransferase and serum total bilirubin, such as viral hepatitis, alcohol abuse, ischemia, preexisting liver disease...

Still reading and digesting. Might go back and buy the article recently published in Cell re disease modification. There is a lot in the FDA postings. Glad oncology experts will be able to debate the pro’s and con’s. CKTC’s point about the final question is central. I think it can be boiled down to ...

Mistergern, you are right, I don’t really don’t know what the FDA will do. I was viewing this as an up or down vote. I just wanted to be sure Bridge had the opportunity to clarify his comments. My comments were based only on not seeing any statement in the FDA material that an additional study was w...