ImetelChat

Kmall, yes it certainly implies that the FDA has passed on production and safety. I wonder if it means that an expert panel has already been convened or will be deemed unnecessary (that seems unlikely given the new class of agent status). In any case it appears to be a preliminary endorsement by the...

RC, I wouldn’t read anything into that article . It’s just a recap of the EHA written by an MD who has gone into medical journalism.

FDA acceptance of EAP is tantamount to eventual acceptance of NDA and subsequent MA.

Compassionate use. Good news for patients .

I do not think you are correct. Chip has not said “ bigger than all of us” since he first took over the company. TA therapeutics has been worthless and Chip has appropriately distanced himself from it.

I was specifically thinking about multiple myeloma and the MM stem cell as a future target. Time will tell.

Jay, Could be but I think decision to treat other diseases will be data driven and incremental.

Most of us reviewed the recent event which included a representative from a patient advocacy organization. John’s comments seemed at times like he was talking to someone not in the room. Stay with me here. When John said it was important to keep an open mind, just who was that comment directed to? B...

Hey guys, you’re making me choke up! Thanks for these most kind words.

Over the years within these pages many points have been made that are only now being more widely recognized as correct, important, on target and well, you get the idea: 1. Imetelstat strikes at the root of an an incurable disease, while it doesn’t cure it, it is the best thing around compared to any...

Jingle, as in love, many are willing, few are compatible.

Hence the pony tail (to your last point). Yes, John will have the last word. (As a real fortune cookie I got once said: “he who laughs laughs, laughs laughs.”) He definitely presented some subtle messages. For example: 1. J and J, you blew it and should have been more patient, now we own the brain d...

Thanks Jay,

I was unable to attend. Did anyone tune in? Hope this was archived.

We know that the natural history of MF appears to be altered in the PII IMbark study with a doubling (!!) of LE. If confirmed with the PIII MF study then indices such as PFS, OS, symptom modification, bone marrow picture will be proven in beyond a shadow of a doubt. What about with MDS? The natural ...

If Geron chooses to not PR the NDA filing, I would not be surprised. It’s really a non event. They said they would file in June and no doubt the will or they have. They just might choose not to make that event public. What is important is whether the FDA accepts the filing (60 days from the initial ...

From the Geron website: Join us for an Endpoints Webinar - Blood cancer breakthroughs: what’s next for underserved markets This live panel event on June 20 will feature experts from industry, academia and advocacy who will review the current unmet need for lower risk MDS patients, explore treatments...

It’s a PR program which includes a representative from the MDS society.

June 20th.