ImetelChat

Thanks for posting this Commsman. I always wondered years ago why Geron had to go through the trouble of getting approval for pediatric MDS (or was it MF) when virtually no children got that particular disease. I asked Geron about it then and was told it was just a requirement from the EU. Now thing...

A little lite background reading:

https://www.nature.com/articles/s41419-020-2298-2

Kmall, Good call on the high powered corporate attorney hires by the way.

RC and Jingle, in all the years I have been following Geron, there has never been a late breaker. The ongoing P II high risk MDS/AML study is not yet full enrolled. It would be extraordinary for Geron to break protocol and release data before completion of the study but I suppose if the results just...

https://www.cell.com/cell-stem-cell/ful ... all%3Dtrue

We will definitely be hearing more from her and about her in the future.

RC, any speculation as to what those CT orders were related to? It’s now four years later. Wonder if they are still relevant or related to programs that Geron didn’t want the competition to get their hands on.

Mr.G, good question. As you can see on clin trials site, there have been many solid tumor studies from over a decade ago that failed. Nonetheless less, new combinations might be tried or new ways up inhibit telomerase (e.g. MAIA or Geron’s as yet to be revealed, oral agent in early development) coul...

Mistergern, yes this seminal article article was first posted on YMB (not by me) and subsequently reposted here on Oct 31st. It’s pretty amazing work that reflects 5 years of nonstop hard work by Dr. Lane and his team with special recognition to the lead author Dr. Claudia Bruedigam. While this is a...

Jay, we were also led to believe priority review was a strong possibility. It didn’t happen. It’s not impossible that the FDA will just approve outright but I wouldn’t hold my breath.

Kmall, I was amazed at your numbers from several years ago, thinking them perhaps too optimistic. Now they look spot on and sagacious. Remarkable. Anyway, you’re gonna need a bigger boat. The question is will it be in this life or the next…. :). As always, Thanks for your massive contributions here....

JS says ADCOM 4 to 6 weeks pre PDUFA

HI thank you for this distillation. I count 4 abstracts. One oral and three posters. It’s easy to over count with the ASH format such as it is.

LWS, enough. We have no idea when the ADCOM meeting will be scheduled. Much more likely to be scheduled much closer to June date. Wishing and repetition does not and will not make it so. You are getting very close to requiring the red pencil.

KT, to be sure, John can’t be pleased with the FDA and neither should we, or doctors, or patients, or lenders, (oh wait they get more months of interest as the loan payback is delayed) or Wall Street (oh wait, they get to issue more stock and take large fees). So with some exceptions, no one is happ...

Where you see agreement, I can assure you there is no agreement and won’t be until the FDA says there is.

So wonderful to see Claudia’s youthful crackling intelligence and enthusiasm and Steven’s gravitas. 5 years of hard lab work, no vacations and the reward of a discovery of a new pathway! Can’t wait for the abstracts and preliminary clinical results. Kudos! (Nobel committee take note…)

What you are missing is that no amount of wishful thinking will change the FDAs schedule.

The case study at the end was unusual as it said nothing about how this lovely lady actually did with Imetelstat. Response? Remission? I suspect heavy censorship until presentations at scientific meetings.

https://medicalxpress.com/news/2023-10- ... ncers.html

Even better but not as succinct as ChatGPT!

Gotta love that!

https://www.nature.com/articles/s43018- ... 20efficacy.

Kmall loves him some ferroptosis!