ImetelChat

Signet 01, you are quite correct, but the CD was to be based largely on the MF data if I remember correctly. Later Scarlett said Janssen would also take the MDS data into consideration before making a final decision. Regards, bp

Well its been about 14 months since Gernobyl. Since that time (ignoring the stock price) some very good things have happened. We have a first class management and development team, fast track in two indications, money in the bank, optimistic meetings with the FDA and multiple signals that manufactur...

I would submit that that need is not met. Rux is a treatment for symptoms but has not been clearly associated with disease modification. With front line there is potential to change the course of a uniformly fatal disease. I think the potential to help many more patients live longer and better is be...

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...

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

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

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...

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...

Nope, no surprises, no updates, some early work re combo therapy. Waiting for FDA meeting.

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...

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...

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. “

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...

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...

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...

Seems to be a rehash of old data from 2011 ASH abstract bp