Search found 103 matches

by KTArsenal
Thu Mar 21, 2024 12:53 am
Forum: ImetelChat
Topic: FDA v. Geron
Replies: 35
Views: 9407

Re: FDA v. Geron

If 12-2 doesn't hold any weight, then the moon is made of cheese.
by KTArsenal
Sun Mar 17, 2024 6:35 pm
Forum: ImetelChat
Topic: Vote 12-2 in Favor
Replies: 9
Views: 2023

Re: Vote 12-2 in Favor

Similar to a priority review pathway, an unmet need usually addressed by orphan products tends to increase the likelihood of approval.

Paraphrasing here, but you get the point.

Pink.citeline.com was used for this sourcing material.
by KTArsenal
Fri Mar 15, 2024 10:12 am
Forum: ImetelChat
Topic: Giving Thanks to Fish Jr, Biopearl, Kmall & company
Replies: 2
Views: 713

Re: Giving Thanks to Fish Jr, Biopearl, Kmall & company

Well written, well said.

Not too much to add except for yes.

Thanks, guys.
by KTArsenal
Fri Mar 15, 2024 12:36 am
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5589

Re: March 14th

Cheers to a nice medium-brew coffee and a bagel with cream cheese or butter and lox. Whatever!

Shots of espresso all around!
by KTArsenal
Fri Mar 15, 2024 12:15 am
Forum: ImetelChat
Topic: Dr. Feller
Replies: 0
Views: 594

Dr. Feller

With all of the negative talk surrounding the abrupt departure of triple Dr. Rizo, it's COMPLETELY apparent that Dr. Feller was an easy choice to replace Dr. Rizo's unenviable position as CMO for Geron. She's a goddamned gem. Well spoken (unlike myself), brilliantly adept at explaining the CT data, ...
by KTArsenal
Thu Mar 14, 2024 10:45 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5589

Re: March 14th

I think shots are in order.

12-2 should definitely be shots in order.

What's your flavor?
by KTArsenal
Thu Mar 14, 2024 7:00 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5589

Re: March 14th

Again, I believe the FDA *has* to be heavy-handed in regards to efficacy and safety profile.

After all of the human MDS stories using imetelstat and doctor's approvals for using imetelstat, this committee would be ghoulish to not approve imetelstat for a therapeutic option in MDS.

Period.
by KTArsenal
Thu Mar 14, 2024 6:23 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5589

Re: March 14th

I believe--could be wrong--it's faster to approval here in the U.S. than it is abroad, believe it or not. That's one scenario.

I think the other is the FDA is the "gold standard" for a drug's approval process. Unless you're big pharma, and then it's basically a rubber stamp from the FDA.
by KTArsenal
Thu Mar 14, 2024 5:25 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5589

Re: March 14th

The safety review team never cancelled one MDS clinical trial, either. I've got to believe that the FDA has to be hyper-critical and overly dramatic concerning safety and efficacy with a new molecule applying for an NDA. So far, Dr. Feller is just so good. If we get an approval nod from this committ...
by KTArsenal
Thu Mar 14, 2024 4:43 pm
Forum: ImetelChat
Topic: March 14th
Replies: 27
Views: 5589

Re: March 14th

Yep, the very first FDA presenter was visibly nervous and her voice was incredibly shaky.

Faye Feller is just an incredible orator. She's a home run hitter.
by KTArsenal
Wed Mar 13, 2024 10:13 pm
Forum: ImetelChat
Topic: CKTC
Replies: 8
Views: 1932

Re: CKTC

I'd like to inject this entire thread directly into my veins.

Thanks for everything, even if we come up short. Cheers 🍻
by KTArsenal
Wed Mar 13, 2024 10:10 pm
Forum: ImetelChat
Topic: Basic Considerations....
Replies: 13
Views: 2636

Re: Basic Considerations....

Links don't work.

What's your synopsis on those dead space links?
by KTArsenal
Wed Mar 13, 2024 12:04 am
Forum: ImetelChat
Topic: Risk vs. Benefit
Replies: 6
Views: 1719

Re: Risk vs. Benefit

Which Geron experts do we expect to speak on the behalf of imetelstat? So far, Dr. Hunter can be ASSURED he's there as an imetelstat detractor, and for me, that's plainly obvious, if he's on the ADCOM review board. Let's hope that this committee's questions about imetelstat's safety and efficacy are...
by KTArsenal
Tue Mar 12, 2024 11:16 pm
Forum: ImetelChat
Topic: Risk vs. Benefit
Replies: 6
Views: 1719

Re: Risk vs. Benefit

Will the panel also include patients who did not benefit from imetelstat, and will they be able to cry wolf due to lack of efficacy and cytopenias? I feel like the FDA might have the upper hand in this Big Pharma chess game. Let's be honest: The FDA is basically stating that Geron cooked the efficac...
by KTArsenal
Mon Mar 04, 2024 1:27 am
Forum: ImetelChat
Topic: Kudos
Replies: 12
Views: 2508

Re: Kudos

Namebackwards could've been writing on Twitter and imetelchat from a local library or somewhere else with a common IP address. Even if red flags are raised it's easy to simply disappear. I agree that sdrawkcabeman spoke eloquently and had imetelstat information that the common man should not. This i...
by KTArsenal
Thu Feb 29, 2024 11:07 pm
Forum: ImetelChat
Topic: Big boys get FDA Priority review.....
Replies: 3
Views: 893

Re: Big boys get FDA Priority review.....

In fairness to those suffering with MDS, the FDA should've granted priority review.

I've looked and I cannot find FDA transparency in declining priority review when priority review request was granted years beforehand.
by KTArsenal
Thu Feb 22, 2024 9:20 pm
Forum: ImetelChat
Topic: Blood
Replies: 3
Views: 957

Re: Blood

Come for the imetelchat, stay for the Antarctic marine biology lesson.
by KTArsenal
Wed Feb 21, 2024 2:10 am
Forum: ImetelChat
Topic: Domino's keep falling for Gilead......
Replies: 1
Views: 877

Re: Domino's keep falling for Gilead......

Abbvie's CEO Richard Gonzalez is being replaced come summer of this year.

BP's getting roughed-up and making significant changes in leadership--and profitability outlook--quite early on this year.
by KTArsenal
Wed Feb 14, 2024 12:59 am
Forum: ImetelChat
Topic: Vanguard Group on board big time!
Replies: 1
Views: 734

Re: Vanguard Group on board big time!

Malvern, PA is a very affluent suburban home of many Philadelphian's that work in the city.

Chester County has its ups and downs but Malvern is an up, if you're into that sorta thing.
by KTArsenal
Tue Feb 13, 2024 10:59 pm
Forum: ImetelChat
Topic: ADCOM
Replies: 96
Views: 293912

Re: ADCOM

Sorry for the earworm.

Dr. Rizo I had your number,
I wanted to make you mine.
Dr. Faye now has your number,

867-5309