Search found 303 matches

by biopearl123
Sun Dec 22, 2019 9:06 pm
Forum: ImetelChat
Topic: Parsing the obnubulate Scarlett
Replies: 6
Views: 2709

Parsing the obnubulate Scarlett

What to make of the last press release re the EOP2 meeting with the Feds? Here we have this:"Based on feedback from the meeting, over the coming months Geron plans to submit several Phase 3 trial design proposals in relapsed/refractory MF and to have further discussions with the FDA regarding potent...
by biopearl123
Fri Dec 20, 2019 5:16 pm
Forum: ImetelChat
Topic: AGIO <--> GERN ....CoRelation?
Replies: 2
Views: 1418

Re: AGIO <--> GERN ....CoRelation?

I don't think its a matter of number of patients but in Agios case a defined molecular target IDH1, something present in <4% of MDS patients. The FDA seems to like targeted molecular end points. bp
by biopearl123
Thu Dec 19, 2019 12:04 am
Forum: ImetelChat
Topic: FDA meeting Press Release
Replies: 4
Views: 1823

Re: FDA meeting Press Release

rccola, I don't see why the FDA should feel compelled to grant AA without some period of time to evaluate whatever was presented at the meeting. I am not sure that the jury isn't still out. bp
by biopearl123
Wed Dec 18, 2019 7:44 pm
Forum: ImetelChat
Topic: Registration
Replies: 0
Views: 1958

Registration

I just deleted another 6000 (!!) bogus registration attempts. I can only hope that there were some legit requests buried in these requests but I truly have no way to know. So if you are sincerely interested in posting here please send me a PM on SA and I will watch for your request and allow activat...
by biopearl123
Wed Dec 18, 2019 12:23 am
Forum: ImetelChat
Topic: Thoughts on the appendix
Replies: 1
Views: 1077

Thoughts on the appendix

No not that appendix, this one: https://www.nejm.org/doi/suppl/10.1056/NEJMoa1310523/suppl_file/nejmoa1310523_appendix.pdf As part of the 2015 Tefferi article in the NEJM the 4 CR or PR patients were presented in the appendix. It is worth a read. And yes Bill, for unknown reasons Tefferi "damned wit...
by biopearl123
Thu Dec 12, 2019 4:17 am
Forum: ImetelChat
Topic: Musings on what Scarlett will bring to the FDA
Replies: 2
Views: 2020

Re: Musings on what Scarlett will bring to the FDA

Nope, no surprises, no updates, some early work re combo therapy. Waiting for FDA meeting.
by biopearl123
Wed Dec 04, 2019 7:12 pm
Forum: ImetelChat
Topic: Musings on what Scarlett will bring to the FDA
Replies: 2
Views: 2020

Musings on what Scarlett will bring to the FDA

I thought it might be fun to compile a list of what might go before the FDA at the end of PII meeting presumptively scheduled for March 2020. I invite board members to add or subtract and to help rank order in terms of importance: 1. The MF study that demonstrates significant MOS improvement. That d...
by biopearl123
Sat Nov 30, 2019 11:06 pm
Forum: ImetelChat
Topic: New article re ET
Replies: 8
Views: 2953

Re: New article re ET

Hunting, you are right about that. The great unknown and Scarlett’s hidden card up his sleeve is whether “disease modification” extends to altering progression to AML. I have submitted this question to annual meetings for the past few years but it has never been adequately addressed. In theory, this...
by biopearl123
Sat Nov 30, 2019 8:52 pm
Forum: ImetelChat
Topic: New article re ET
Replies: 8
Views: 2953

Re: New article re ET

Well, here is how Blood Advances defines “Stimulus Report” : ”To complement the clinical case reports, we also recognize that there can be more basic scientific insights that also can provide novel information or mechanisms in a short format that we have termed Stimulus Reports. “
by biopearl123
Sat Nov 30, 2019 8:32 pm
Forum: ImetelChat
Topic: New article re ET
Replies: 8
Views: 2953

Re: New article re ET

Hi Hunting, the issue for ET is that primary treatment is essentially aspirin so there is no market despite impressive anticlonal data. This study emphasizes the selective nature of Imet (a very good attribute) across myleoproliferative diseases, in this case, ET, complementing the previously presen...
by biopearl123
Wed Nov 27, 2019 10:34 pm
Forum: ImetelChat
Topic: New article re ET
Replies: 8
Views: 2953

Re: New article re ET

So why are we seeing old ET data repackaged and published now? The article I posted is a rehash of 2011 ASH abstract, I don't see anything really new, does anyone else? Dr. Boerlacher has basically been MIA and I have not seen her as an integral part of the MF or MDS studies. This is a glaring absen...
by biopearl123
Wed Nov 27, 2019 10:34 pm
Forum: ImetelChat
Topic: New article re ET
Replies: 8
Views: 2953

Re: New article re ET

So why are we seeing old ET data repackaged and published now? The article I posted is a rehash of 2011 ASH abstract, I don't see anything really new, does anyone else? Dr. Boerlacher has basically been MIA and I have not seen her as an integral part of the MF or MDS studies. This is a glaring absen...
by biopearl123
Wed Nov 27, 2019 3:50 pm
Forum: ImetelChat
Topic: New article re ET
Replies: 8
Views: 2953

Re: New article re ET

Seems to be a rehash of old data from 2011 ASH abstract bp
by biopearl123
Mon Nov 25, 2019 7:14 pm
Forum: ImetelChat
Topic: ASH 2019
Replies: 3
Views: 1794

Re: ASH 2019

Hi Ryan, the abstract makes mention of the Part I results. If this were an oral presentation the think an update of the Part I data would be appropriate and probably part of the presentation. The poster however will probably just reflect the abstract as presented (but I would love to see more data t...
by biopearl123
Mon Nov 18, 2019 10:24 pm
Forum: ImetelChat
Topic: Dr. Uwe Platzbecker
Replies: 1
Views: 1302

Re: Dr. Uwe Platzbecker

Ryan, thanks for posting. Good point. Interesting that the primary presenter is European and the big news clinical news seems to find its way to EHA over ASH. bp
by biopearl123
Mon Nov 18, 2019 7:57 pm
Forum: ImetelChat
Topic: The "other two" abstracts
Replies: 1
Views: 1886

The "other two" abstracts

First off, thanks to recent posters, hunt and commsman, for their contributions and thoughts. I wanted to mention the "other two" ASH abstracts related to Geron but not acknowledged in the recent PR. You can read them here (in addition to the two that Geron has referenced): https://ash.confex.com/as...