Search found 1669 matches
- Thu Jun 29, 2023 10:54 pm
- Forum: ImetelChat
- Topic: This must be HUGE!
- Replies: 11
- Views: 2524
Re: This must be HUGE!
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...
- Thu Jun 29, 2023 4:39 pm
- Forum: ImetelChat
- Topic: This must be HUGE!
- Replies: 11
- Views: 2524
Re: This must be HUGE!
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.
- Thu Jun 29, 2023 3:43 pm
- Forum: ImetelChat
- Topic: FDA acceptance of EAP
- Replies: 2
- Views: 1671
FDA acceptance of EAP
FDA acceptance of EAP is tantamount to eventual acceptance of NDA and subsequent MA.
- Thu Jun 29, 2023 3:19 pm
- Forum: ImetelChat
- Topic: This must be HUGE!
- Replies: 11
- Views: 2524
Re: This must be HUGE!
Compassionate use. Good news for patients .
- Sun Jun 25, 2023 2:40 am
- Forum: ImetelChat
- Topic: i believe chip has been trying to let us in on the newest development
- Replies: 1
- Views: 1156
Re: i believe chip has been trying to let us in on the newest development
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.
- Fri Jun 23, 2023 10:59 pm
- Forum: ImetelChat
- Topic: Parsing Scarlett: Just who exactly is he talking to?
- Replies: 3
- Views: 1553
Re: Parsing Scarlett: Just who exactly is he talking to?
I was specifically thinking about multiple myeloma and the MM stem cell as a future target. Time will tell.
- Fri Jun 23, 2023 4:06 pm
- Forum: ImetelChat
- Topic: Parsing Scarlett: Just who exactly is he talking to?
- Replies: 3
- Views: 1553
Re: Parsing Scarlett: Just who exactly is he talking to?
Jay, Could be but I think decision to treat other diseases will be data driven and incremental.
- Fri Jun 23, 2023 6:32 am
- Forum: ImetelChat
- Topic: Parsing Scarlett: Just who exactly is he talking to?
- Replies: 3
- Views: 1553
Parsing Scarlett: Just who exactly is he talking to?
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...
- Fri Jun 23, 2023 1:14 am
- Forum: ImetelChat
- Topic: Within these pages…
- Replies: 5
- Views: 2779
Re: Within these pages…
Hey guys, you’re making me choke up! Thanks for these most kind words.
- Thu Jun 22, 2023 12:02 am
- Forum: ImetelChat
- Topic: Within these pages…
- Replies: 5
- Views: 2779
Within these pages…
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...
- Wed Jun 21, 2023 3:40 am
- Forum: ImetelChat
- Topic: Let the PR begin
- Replies: 13
- Views: 4728
Re: Let the PR begin
Jingle, as in love, many are willing, few are compatible.
- Tue Jun 20, 2023 11:32 pm
- Forum: ImetelChat
- Topic: Let the PR begin
- Replies: 13
- Views: 4728
Re: Let the PR begin
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...
- Tue Jun 20, 2023 9:52 pm
- Forum: ImetelChat
- Topic: Let the PR begin
- Replies: 13
- Views: 4728
Re: Let the PR begin
Thanks Jay,
- Tue Jun 20, 2023 7:24 pm
- Forum: ImetelChat
- Topic: Let the PR begin
- Replies: 13
- Views: 4728
Re: Let the PR begin
I was unable to attend. Did anyone tune in? Hope this was archived.
- Tue Jun 20, 2023 3:13 pm
- Forum: ImetelChat
- Topic: NDA submitted
- Replies: 22
- Views: 13332
- Tue Jun 20, 2023 1:05 am
- Forum: ImetelChat
- Topic: Are we starting to see a real change in the natural history of MDS?
- Replies: 0
- Views: 9800
Are we starting to see a real change in the natural history of MDS?
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 ...
- Mon Jun 19, 2023 6:14 am
- Forum: ImetelChat
- Topic: If
- Replies: 4
- Views: 2422
If
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 ...
- Sat Jun 17, 2023 3:47 am
- Forum: ImetelChat
- Topic: Let the PR begin
- Replies: 13
- Views: 4728
Re: Let the PR begin
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...
- Sat Jun 17, 2023 3:42 am
- Forum: ImetelChat
- Topic: Let the PR begin
- Replies: 13
- Views: 4728
Re: Let the PR begin
It’s a PR program which includes a representative from the MDS society.
- Fri Jun 16, 2023 6:48 pm
- Forum: ImetelChat
- Topic: Let the PR begin
- Replies: 13
- Views: 4728
Let the PR begin
June 20th.