Search found 1670 matches
- Thu Feb 29, 2024 10:57 pm
- Forum: ImetelChat
- Topic: Big boys get FDA Priority review.....
- Replies: 3
- Views: 913
Re: Big boys get FDA Priority review.....
In fairness to the FDA, if there is such a thing, these drugs are already approved for other indications.
- Thu Feb 29, 2024 3:21 pm
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1614
Re: Absolutely fabulous comments from Dr. Jeffrey Savidge
Point taken, a black box warning is not the end of the world for Imetelstat and would probably not impair appropriate usage of the drug. In my area, drugs like amiodarone, Sotolol, even digitalis would kill in the hands of the inexperienced. Oncologists use very strong drugs and Imetelstat would not...
- Thu Feb 29, 2024 5:10 am
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1614
Re: Absolutely fabulous comments from Dr. Jeffrey Savidge
Pretty scary, that example. No doubt the analysts have financial models with and without the black box warnings and are very interested in whether one might be issued. Considering that a black box warning is conferred when there is are serious adverse reactions that “may lead to death or serious inj...
- Thu Feb 29, 2024 12:47 am
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1614
Re: Absolutely fabulous comments from Dr. Jeffrey Savidge
Operation Kmall was a Herculean undertaking and was a great success lo those many years ago. Our service men deserve the best of care, not to mention the highest respect. When I see a Gold Star family disrespected or a national hero and fine person who has served our country on so many levels like J...
- Wed Feb 28, 2024 11:25 pm
- Forum: ImetelChat
- Topic: Absolutely fabulous comments from Dr. Jeffrey Savidge
- Replies: 6
- Views: 1614
Absolutely fabulous comments from Dr. Jeffrey Savidge
Eloquent, heartfelt, sincere and well informed. Worth a visit to the FDA comments board to review this. Major kudos, sir. On another note, Just a reminder that the cytopenias are not related to toxicity like many chemo agents, this drug does not destroy the bone marrow, it heals it. It’s pretty stra...
- Tue Feb 27, 2024 9:00 pm
- Forum: ImetelChat
- Topic: ODAC
- Replies: 0
- Views: 1207
ODAC
https://www.regulations.gov/document/FDA-2024-N-0016-0001 Comments submitted before Feb 29th will be presented to the committee. Comments after that date will be taken into consideration by the FDA. If you or anyone you know want their comments considered, there is a time deadline. So far only a few...
- Tue Feb 27, 2024 6:06 am
- Forum: ImetelChat
- Topic: A blessing from the hepatologists Major hat tip to Wildrides YMB
- Replies: 5
- Views: 1592
Re: A blessing from the hepatologists Major hat tip to Wildrides YMB
Ryan, are you surprised? I think this is the tip of the iceberg.
- Tue Feb 27, 2024 3:38 am
- Forum: ImetelChat
- Topic: A blessing from the hepatologists Major hat tip to Wildrides YMB
- Replies: 5
- Views: 1592
- Mon Feb 26, 2024 5:27 am
- Forum: ImetelChat
- Topic: The cost to develop a new drug
- Replies: 4
- Views: 1123
The cost to develop a new drug
Yes we have seen a lot of dilution but how much would Janssen have spent to do the same for Imetelstat?
https://www.genengnews.com/gen-edge/the ... 3-billion/
https://www.genengnews.com/gen-edge/the ... 3-billion/
- Thu Feb 22, 2024 4:24 am
- Forum: ImetelChat
- Topic: Blood
- Replies: 3
- Views: 989
Blood
I have reviewed the recent discussion. We have much to learn from other species and as Jerry Garcia would say, “the wonders of nature”. Kmall’s posts remind us of the amazing beauty around us and how the species intertwine and the respect we should have for our fragile ecosystem. Who would know that...
- Wed Feb 21, 2024 9:32 pm
- Forum: ImetelChat
- Topic: THANK YOU IMETELCHAT BOARD !!!!!
- Replies: 19
- Views: 2299
Re: THANK YOU IMETELCHAT BOARD !!!!!
I am traveling and will give this thread the scrutiny it deserves when I can
- Wed Feb 21, 2024 1:49 am
- Forum: ImetelChat
- Topic: A wonderful summation of the state of things
- Replies: 4
- Views: 937
A wonderful summation of the state of things
This is the opening paragraph of a paper by Chandhok and Sekeres in "Leukemia" Feb 15th which I can't copy here sums up the sorry state of affairs in the current treatment of LR/MDS and confirms the absence of data to support improved survival (with current treatment) and the dreadful dependence of ...
- Tue Feb 20, 2024 5:33 pm
- Forum: ImetelChat
- Topic: Everything is relative
- Replies: 3
- Views: 603
Re: Everything is relative
Kmall, I stand happily corrected on both points
- Tue Feb 20, 2024 4:09 pm
- Forum: ImetelChat
- Topic: Everything is relative
- Replies: 3
- Views: 603
Everything is relative
Some as asked for a reckoning of side effects from Imetelstat. Fair enough. I think however having some framework that allows evaluation of alternatives help with perspective. Let’s start with the side effects of blood transfusions: 1. Volume overload (many patients with MPD have concurrent vascular...
- Mon Feb 19, 2024 10:23 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 35
- Views: 10216
Re: FDA v. Geron
The editorial written by Dr. Patniak is summarized in my Dec 5th post. You do have access if you wish, there is a modest fee to Lancet for time limited access.
- Mon Feb 19, 2024 4:56 pm
- Forum: ImetelChat
- Topic: FDA v. Geron
- Replies: 35
- Views: 10216
Re: FDA v. Geron
LWS, like many things in life, this is not binary. It might be valuable to go back and review the Mayo editorial in Lancet which tries to balance a ringing endorsement with an an examination of the potential flaws in the IMerge study and the cautionary approach that must be used with any completely ...
- Mon Feb 19, 2024 12:09 am
- Forum: ImetelChat
- Topic: THANK YOU IMETELCHAT BOARD !!!!!
- Replies: 19
- Views: 2299
- Sun Feb 18, 2024 4:17 pm
- Forum: ImetelChat
- Topic: meanwhile, back on topic
- Replies: 25
- Views: 4157
Re: meanwhile, back on topic
Jay, I could be wrong but the way I read it is that these are options to buy stock at 2.10 anytime over the next ten years were awarded as a from of incentive/compensation. They own the options to buy. If the stock goes up it’s a bargain, they can buy at 2.10 if it goes down the options are worthles...
- Sun Feb 18, 2024 3:20 am
- Forum: ImetelChat
- Topic: meanwhile, back on topic
- Replies: 25
- Views: 4157
Re: meanwhile, back on topic
These are option awards with a 2034 expiration date.
- Sun Feb 18, 2024 12:32 am
- Forum: ImetelChat
- Topic: meanwhile, back on topic
- Replies: 25
- Views: 4157
Re: meanwhile, back on topic
Seedylemon, I think it might be worth trying to clarify your post. Dr. Scarlett along with other officers received option awards that can be exercised for a certain price anytime over the next ten years. That is not the same as buying shares outright or exercising options to guarantee a specific pri...