ImetelChat

Regarding the IND 1951 (pilot study) recent change on CT form, Line 2 (regulatory authority), now specifies as bio pointed out: 'FDA'. Perhaps (a very big perhaps), it relates to collaborative work of FDA and EMA with FDA as lead agency - if pilot data might be used at some point for European approv...

John just back from Mayo. He is very good. All blood counts close to normal or baseline, no increase in circulating blasts, other prognostic indicators like LDH stable, and slow increase in one liver enzyme only as expected and common in many cancer treatments with liver damage associated with disea...

My thoughts on pilot study in response to discussion: 1. I think the pilot has not been updated in any meaningful way on the CT site. It is pretty much on autopilot with those left from the 33 subset. I doubt we will ever get data on the 81 patients as many left with the FDA hold and disrupted the s...

Hunting - Applause for your post. Exactly. I can't believe John has to travel 2000 miles every 3 weeks for more than 3 years - when imetelstat is being infused in others (just because they took jakafi and john took hydroxyurea) 20 minutes down the road. And, that is a minor complaint compared to tho...

Me, either.

Hi bio - I agree with all you say regarding Dr. Tefferi. I think he must be frustrated. I also thinks he considers liver enlargement - while very uncomfortable for patient - in the same symptom category and no more/no less regarding prognosis than severe fatigue and chronic fever. I think anemia is ...

I realize there is much discussion on whether or not this is a frontline trial and how fast JJ can/will roll 4.7 patients into 9.4 dose. I will add my thoughts this weekend. Have a great day.

Hi bio - A couple of quick thoughts. 1. I am glad to see some discussion that 4.7 mg was lowest dose with any activity and so I think that dose was used to randomly assign for trial design purposes with expectation patients would need more. And if patients are healthy enough to move to higher dose a...

Thank you used car. Thank you for the good energy, too. This reminds me of the terrible, horrible, very bad FDA hold. The hold was resolved sooner rather than later. 9.4 mg at 24 weeks is our ride or die. Good luck and I hope you can get a new car soon!

Bio - Excellet concise summary. What you say we know - we know. Based on update - no more and no less. I did want to add 2 cents on comparing Mayo and Imbark MF populations as is much discussed on SA. More severe forms of MF - degree of disease and prognosis - is either intermediate high risk or hig...

Thanks Fish, Laughing. No, you are correct, investors are very smart in this manipulated game and I should have not used the word "dumb". I have great respect for that skill if not always some of the ethics. I actually edited (I love that edit function!) before your comment realizing that what I pos...

Some "post-update" thoughts I would share prompted by reading SA posts and many in response to fish posts: 1. Blood improvement and other symptom response is subsequent to bone marrow fibrosis response. And blood response decreases symptoms. Like a marrow transplant - eventually new marrow makes bet...

Thanks fish - Just needed a break from posting. Will try to post when there are developments and add my perspective (or interesting speculation that pops into my mind) but living a healthy happy life now (and work) does get in the way of my MF hobby. John's only option prior to imet - post hydrea - ...

Thanks bio. Edited my error. You are, of course, correct. Love the editing function here. I am personally not too worried at the MF 12 weeek results or lack therof in that timeframe. I think in Mayo pilot MDS + effect may have been quicker overall than MF + effect. That leads me to a post I noticed ...

John was diagnosed with intermediate high risk - although borderline high risk - with complex karotype. He was previously misdiagnosed and so hard to say exact MF diagnosis date, but at least a year prior to Mayo treatment with imetelstat. He was deteriorating on hydroxyurea and was refractory to it...

I have read the comments here and some SA comments about the update today. I will add mine in 3 posts. First: what we know. 1. MDS results consistent with Mayo results. MF not there yet. 2. The study is not "suspended". Geron: why did you even use that language in a press release? I again volunteer ...

Hi Fish - I think this must come as a surprise especially announced on a Sunday morning for next day. Hopefully, some good 'new' news. John is great more than 4 years after diagnosis of high risk MF. I don't think John is the only one - especially given on-going expansion of distribution - I mean st...

Thank you, Greg. YMB finally tried my end stage patience. Your kind words mean a lot and I know there were many more ethical investors on that YMB than not. Just needed a rest. When I first posted, I did not expect to be posting this long...expected to post a couple of times and then ASH 2013 good n...

Thanks fish and bio - No, gag order. However, the information is now held much more tightly by JJ and Mayo is not at much liberty to speak. John cannot move to another site at this time. All original imetelstat patients have to continue at Mayo Clinic. We are working on trying to change that decisio...

Hi Fish - I am on here. Sorry for the hiatus in posting. Yahoo posters violated boundaries so your site is much better option - and I finally got into it again. Thanks for the help. John is still traveling to Mayo every 3 weeks for his 7.5 mg dose. His disease has completely stabilized and he is doi...