Search found 23 matches

by FC4364
Mon Aug 21, 2023 3:06 pm
Forum: ImetelChat
Topic: FDA accepts NDA
Replies: 19
Views: 9656

Re: FDA accepts NDA

Houston, Crawler Transporter has delivered rocket to launch pad. Mobile Launch Table is connected to launch pad. Final Countdown begins Main fuel tanks are filled Launcher subsystem being checked Flight Programme is loaded into computer Countdown at - 6 min 30 s countdown is automatic A shout out to...
by FC4364
Thu May 18, 2023 5:13 pm
Forum: ImetelChat
Topic: AML trial update
Replies: 5
Views: 2910

Re: AML trial update

High Risk MDS and AML were recently discussed by the good DR, and we know that as of right now the NDA appears to be on track. Indications at this point appear to show they are more than willing to go it alone. So, one wonders where this can go and where will it be in 2, 3 or 5 years. No high projec...
by FC4364
Sat May 13, 2023 5:34 pm
Forum: ImetelChat
Topic: My exact date prediction for the May Miracle
Replies: 20
Views: 14241

Re: My exact date prediction for the May Miracle

Lots of chatter on YMB by Anthony in regards to FDA calendar and the Prescription Drug User Fee Act (PDUFA) date sometime in August.
by FC4364
Thu Apr 20, 2023 7:36 pm
Forum: ImetelChat
Topic: Imetelstat Franchise
Replies: 32
Views: 16393

Re: Imetelstat Franchise

GERON reported that as of 03/31/2023 it had over 400 million in financial resources on balance sheet that supports a launch uncompromised by financial constraints.
by FC4364
Thu Dec 22, 2022 8:19 pm
Forum: ImetelChat
Topic: That awful rocking horse is gone!
Replies: 10
Views: 2029

Re: That awful rocking horse is gone!

Very Professional. Leaves no confusion.
by FC4364
Mon Feb 21, 2022 9:27 pm
Forum: ImetelChat
Topic: There are many ways to think about partnering
Replies: 177
Views: 368203

Re: There are many ways to think about partnering

It makes no sense to apply for ILAP, receive it and then just sit and wait for Father Time to do the heavy lifting. If GERN applied for ILAP, then the intention is to pursue early approval. Matters not if they have yet applied for MA. Processes associated with ILAP will need to be observed first. No...
by FC4364
Fri Dec 10, 2021 4:57 pm
Forum: ImetelChat
Topic: Fellow Board Members
Replies: 9
Views: 2517

Re: Fellow Board Members

Excellent News. Thank you BP.
by FC4364
Fri Nov 26, 2021 6:06 pm
Forum: ImetelChat
Topic: Sherlock Holmes and the QT interval
Replies: 22
Views: 6795

Re: Sherlock Holmes and the QT interval

DDD on YMB, points out that ---- From EU clinical site "Protocol Amendment: 31 August 2017 Attachment 11: Ventricular Repolarization Substudy at Selected Sites Study Objectives To evaluate the effect of imetelstat on ventricular repolarization in a subset of subjects in Part 2 from selected clinical...
by FC4364
Thu Nov 25, 2021 8:26 pm
Forum: ImetelChat
Topic: Sherlock Holmes and the QT interval
Replies: 22
Views: 6795

Re: Sherlock Holmes and the QT interval

No announcement from company, then not a material event. Now, not to say one is not forthcoming, but for now, no and if there is one to be made, it would need to be made soon, very, very soon, like tomorrow. Pawns in the game are constantly being moved around and this could be just another step for ...
by FC4364
Thu Nov 25, 2021 8:22 pm
Forum: ImetelChat
Topic: Sherlock Holmes and the QT interval
Replies: 22
Views: 6795

Re: Sherlock Holmes and the QT interval

No announcement from company, then IMO, not a material event. Now, not to say one is not forthcoming, but for now, no and if there is one to be made, it would need to be made soon, very, very soon, like tomorrow. Pawns in the game are constantly being moved around and this could be just another step...
by FC4364
Tue Aug 31, 2021 4:11 pm
Forum: ImetelChat
Topic: And another window into November opens…
Replies: 4
Views: 1779

Re: And another window into November opens…

Interesting that we now have a tease for November which may forecast things to come in the way of new trials (Possibly). Either way, sort of remember someone at GERON saying no new trials until the low hanging fruit of MF/MDS had approval. Please correct this, if wrong but seem to remember it being ...
by FC4364
Wed Jul 07, 2021 12:59 am
Forum: ImetelChat
Topic: New presentation
Replies: 11
Views: 4778

Re: New presentation

Curious and may have missed it but why is there a new presentation? Did it just pop up out of the blue? What is the motivation for it? Thanks in advance
by FC4364
Thu Jan 28, 2021 5:07 pm
Forum: ImetelChat
Topic: short interest
Replies: 17
Views: 8481

Re: short interest

Lots of folks talking about the short position and how the shorts have to buy back approximately 60 + million shares and the implied carnage that goes with it. It is my understanding that all a short(s) has to do is declare to the Depository Trust Clearing Corporation (DTCC) that they do not have th...
by FC4364
Sun Jan 10, 2021 10:18 pm
Forum: ImetelChat
Topic: short interest
Replies: 17
Views: 8481

Re: short interest

Do the shorts know something we do not? While that is possible, not sure it is feasible or realistic? Is it possible that someone in a position of trust is playing both sides of the board? I would believe that before I would believe shorts know more than we do.
In My Opinion, Of Course.
by FC4364
Thu Nov 05, 2020 3:29 pm
Forum: ImetelChat
Topic: ASH presentations
Replies: 4
Views: 2655

Re: ASH presentations

Hat tip to Lazarus, over on YMB. Pointed out there are 19 mentions and 10 presentations involving Imetelstat at ASH this year.

19 mentions and 10 presentations. Exciting !!!

Needless to say, sound of silence from FDA is thunderous.

In My Opinion, of course.
by FC4364
Thu Nov 05, 2020 3:29 pm
Forum: ImetelChat
Topic: ASH presentations
Replies: 4
Views: 2655

Re: ASH presentations

Hat tip to Lazarus, over on YMB. Pointed out there are 19 mentions and 10 presentations involving Imetelstat at ASH this year.

19 mentions and 10 presentations. Exciting !!!

Needless to say, sound of silence from FDA is thunderous.

In My Opinion, of course.
by FC4364
Thu Nov 05, 2020 3:28 pm
Forum: ImetelChat
Topic: ASH presentations
Replies: 4
Views: 2655

Re: ASH presentations

Hat tip to Lazarus, over on YMB. Pointed out there are 19 mentions and 10 presentations involving Imetelstat at ASH this year.

19 mentions and 10 presentations. Exciting !!!

Needless to say, sound of silence from FDA is thunderous.

In My Opinion, of course.
by FC4364
Sat Jul 18, 2020 3:55 pm
Forum: ImetelChat
Topic: Spontaneous remission in high risk MDS/AML
Replies: 3
Views: 2905

Re: Spontaneous remission in high risk MDS/AML

BP, Thanks for the clarification on the Astek combination oral solution for MDS/CMML. It is a step forward in helping folks and hopefully it is a positive for the patients. I still believe Imetelstat was being reviewed for approval by EMA. Just a hunch, no proof but there were interesting events tak...
by FC4364
Tue Jul 14, 2020 4:04 pm
Forum: ImetelChat
Topic: Spontaneous remission in high risk MDS/AML
Replies: 3
Views: 2905

Re: Spontaneous remission in high risk MDS/AML

My thoughts are Imetelstat was up for approval with EMA. This would explain the reduction in shorted shares with really no significant price movement. It would also explain, GERN taking on new high profile partners. Then, FDA approved the drug from Astex Pharmaceuticals and this could be part of the...
by FC4364
Thu Jun 18, 2020 3:17 pm
Forum: ImetelChat
Topic: Upcoming Phase 3 MF Trial
Replies: 4
Views: 3583

Re: Upcoming Phase 3 MF Trial

BP, thank you. Have not had a chance to listen to the presentation and this is prenominal good news. Thanks again. FC