Search found 56 matches

by kmall
Fri Sep 04, 2020 10:21 pm
Forum: ImetelChat
Topic: Orphan being discussed AML/MDS/JMML
Replies: 9
Views: 2002

Re: Orphan being discussed AML/MDS/JMML

Andrew, as you stated earlier, it's a start. Perhaps pediatric is a prerequisite for MA? If it's safe and effective for children then maybe logic or data dictates efficiency in older patients? Would love to get some insight on the EU approval process in general and if this has any bearing for broade...
by kmall
Thu Aug 20, 2020 10:26 am
Forum: ImetelChat
Topic: NEA and Geron - A Perfect Fit
Replies: 0
Views: 888

NEA and Geron - A Perfect Fit

As many of us know, one of the major investors from the most recent round of funding by Geron was NEA Ventures. https://www.nea.com/ They specialize in backing ground breaking companies in Technology and Healthcare. Dr. Scott Gottlieb has returned as a "special partner" after a 2+ year stint as FDA ...
by kmall
Thu Aug 20, 2020 9:32 am
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2358

Re: Re EU MA

Hi Andrew, This is one of those threads that seems to snowball into an avalanche of thoughts and queries, many of which are far out of my realm of understanding ( approval, regulatory and clinical trial process, etc. ) so many thanks to all of those contributing here. With regards to my last posting...
by kmall
Thu Aug 20, 2020 9:32 am
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2358

Re: Re EU MA

Hi Andrew, This is one of those threads that seems to snowball into an avalanche of thoughts and queries, many of which are far out of my realm of understanding ( approval, regulatory and clinical trial process, etc. ) so many thanks to all of those contributing here. With regards to my last posting...
by kmall
Mon Aug 17, 2020 8:04 am
Forum: ImetelChat
Topic: Re EU MA
Replies: 13
Views: 2358

Re: Re EU MA

Thank you all for a very intriguing thread. The initial post which the link for the 67 day EMA OD to approval or MA (Market Authorization) appeared, centered on my thoughts concerning the CD J&J/Geron breakdown and how I believed it was a business rift between the two rather than J&J having only a p...
by kmall
Sun Aug 09, 2020 8:22 am
Forum: ImetelChat
Topic: Once in a while--hat tip to Fan YMB
Replies: 4
Views: 1582

Re: Once in a while--hat tip to Fan YMB

LWS - not sure about the answer to your question regarding EMA OD leading to approval as the next step, however, this touches on FDA and EMA OD comparisons. Of note, only 41% of those cancer drugs who get FDA OD also are granted EMA OD. Hopefully a good sign for Imet. https://www.google.com/url?sa=t...
by kmall
Sun Aug 09, 2020 8:00 am
Forum: ImetelChat
Topic: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 1
Replies: 4
Views: 1775

Re: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 1

Martin, Thanks for the feedback, and yes you are definitely on the list of those I hold in high regard when it comes to thoughts on this company, drug and those who passionatley combat anyone spreading constant FUD regarding both of these. When the ASH 2018 data was revealed I too was like "Ahhh ha....
by kmall
Thu Aug 06, 2020 8:08 am
Forum: ImetelChat
Topic: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 2
Replies: 2
Views: 1380

Re: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 2

Ashish, Appreciate the feedback and also your contributions to Imetelchat. Obviously a good deal of what gets posted by me and others when it comes to this company falls in the speculation category. I had posted the Damanjit link several months ago on the YMB when I first came across it and what a G...
by kmall
Mon Aug 03, 2020 9:46 am
Forum: ImetelChat
Topic: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 2
Replies: 2
Views: 1380

Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 2

Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 2 One of the most significant and meaningful moves by Dr. Scarlett on his road towards approval was the first hire after the J&J CD meltdown. It came with no PR and zero fanfare. The hiring of Damanjit Singh in November,...
by kmall
Mon Aug 03, 2020 9:41 am
Forum: ImetelChat
Topic: Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 1
Replies: 4
Views: 1775

Round Of Applause For A Visionary Leader And A Look Back In The Rear View - Pt. 1

Round Of Applause For A Visionary Leader And A Look Back In The Rear View Congratulations to Dr. Scarlett, Team Geron, Patients in the EU and the shareholders of Geron on this weeks confirmation of Orphan Drug Designation by the EMA. For now, I’ll keep the champagne on ice, however, it seems as if t...
by kmall
Mon Jul 27, 2020 4:11 am
Forum: ImetelChat
Topic: A question for the FDA
Replies: 4
Views: 1159

Re: A question for the FDA

I had tried posting here several weeks ago before leaving FL for NY.....somehow I was locked out via my password - had to create a new one. Traveling by sail has been an incredible experience as a "live aboard".....dodged a number of electrical storms off the FL coast heading north and was able to a...
by kmall
Mon Jun 08, 2020 1:09 pm
Forum: ImetelChat
Topic: Thoughts from the shareholder meeting
Replies: 6
Views: 2299

Re: Thoughts from the shareholder meeting

Hi Cathy, first off welcome to the board. I'm confused as to why you would think I would be displeased with your entry here? If I missed any greetings from you then apologies! Best of wishes for your husbands recovery. I think my mention of Dr. Gottlieb in this thread concerned him most likely not r...
by kmall
Mon Jun 08, 2020 2:32 am
Forum: ImetelChat
Topic: Thoughts from the shareholder meeting
Replies: 6
Views: 2299

Re: Thoughts from the shareholder meeting

Ryan - Great story about Ceaser! I was never naive enough to think that as FDA Director, Dr. Gottlieb actually read my Tweets to his agency - they most likely go nowhere - into the void......however, I always had a notion that Imet was somehow on his radar........now as part of the NEA Team it most ...
by kmall
Mon Jun 08, 2020 1:10 am
Forum: ImetelChat
Topic: Frontline Treatment and a Geron / J&J carbon copy? Pt. 2
Replies: 0
Views: 1370

Frontline Treatment and a Geron / J&J carbon copy? Pt. 2

Finally, slightly off topic, Andrew suggested that I take a look at PRM-151 and the ligand trap therapy that could potentially have an effect on fibrosis. I had never heard of this and just had a chance to briefly look into it yesterday. Immediately, I found a PR from Feb. 13, 2020 about a partnersh...
by kmall
Mon Jun 08, 2020 1:09 am
Forum: ImetelChat
Topic: Frontline Treatment and a Geron / J&J carbon copy? - Pt 1
Replies: 0
Views: 1268

Frontline Treatment and a Geron / J&J carbon copy? - Pt 1

Last week Andrew posed several questions to the Imetelchat board directed at what seems to be Geron’s strategic use of Imetelstat in the IMbark trials towards the latter portion of patient treatment after BAT have failed and prognosis is quite dire. It seems to be a fair assessment of Imetelstats ro...
by kmall
Sun Jun 07, 2020 2:26 pm
Forum: ImetelChat
Topic: Additional thoughts
Replies: 7
Views: 1725

Re: Additional thoughts

Absolutely Andrew! My faith in the FDA has been shaken. Through their own "Clinical Trial Endpoints For the Approval Of Cancer Drugs" - December of 2018 - https://www.fda.gov/media/71195/download Pg. 7 - "Overall survival is defined as the time from randomization until death from any cause and is me...
by kmall
Sun Jun 07, 2020 7:09 am
Forum: ImetelChat
Topic: Additional thoughts
Replies: 7
Views: 1725

Re: Additional thoughts

Hmmmmm.......I think I Tweeted that guy a dozen times or more when he was FDA Director about Imetelstat and the fact that MOS is 3x that of the next BAT.... Hmmmmmm???

Wonder how many patients he could have helped between now and then.........Hmmmmmm???
by kmall
Tue Jun 02, 2020 2:48 am
Forum: ImetelChat
Topic: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size
Replies: 6
Views: 1972

Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Andrew, or perhaps she was directed to Celgene to take a look under the hood of Luspat? You know how Dr. Scarlett has a car thing going on.....
by kmall
Tue Jun 02, 2020 2:41 am
Forum: ImetelChat
Topic: Superb
Replies: 1
Views: 979

Re: Superb

Appreciate the feedback Andrew, and although quite lengthy; it actually didn't seem to be on my word doc. Spacing, the addition of links and the format here made it a 6-part thing, so apologize for that. I've been sitting on 95% of that research from my Op Kmall thing, and I felt that it tied itself...
by kmall
Tue Jun 02, 2020 2:19 am
Forum: ImetelChat
Topic: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size
Replies: 6
Views: 1972

Re: Go Big or Go Home – Pt.3 – Imetelstat’s Potential Market Size

Austin, thank you for sharing your story with the board. It just goes to validate what I've suspected since first hearing about the discontinuation between the two companies. A FIC drug such as Imet and all of the platforms / indications it may be applicable towards would very well be a "game change...