ImetelChat

SEATTLE, Feb. 8, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA:CTIC) today announced that the Company received written communication from the U.S. Food and Drug Administration (FDA) on February 4, 2016, that the FDA has placed a partial clinical hold on the clinical studie...

I took a quick look and I think these are the kind of methods which indeed can improve imetelstat as a platform drug. It is rather technical, so I can not understand it all. Although clinical trials have just started, at Geron and JnJ they probably are already anticipating for imetelstat 2.0. This a...

Hi Hiprock, thanks for your interesting post. I have seen it come by once, but not on this board. I will look it up and come back to it later.

26 April – 01 May 2016 | Liege, Belgium About the conference During the last few years, the telomere and telomerase field has moved from describing parts and local functions of telomeres to integrating them into nuclear biology and organismal well-being in general. For humans, the links with cancer,...

Some other info about the approval process in the EU based on ODD and EMA fast track treatment (the following example is about Emplicit, a drug for MM that received ODD first and now fast track treatment): ===== Because multiple myeloma is rare, Empliciti received an orphan designation from the Comm...

29 January 2016 EMA/COMP/777525/2015 Committee for Orphan Medicinal Products Public summary of opinion on orphan designation - Imetelstat sodium for the treatment of myelofibrosis On 14 December 2015, orphan designation (EU/3/15/1593) was granted by the European Commission to Janssen-Cilag Internati...

Guys, I know its just a trade, but after seeing this much pessimism in GERN, I'm reloading here at 2.80-81. If Gern closes below 2.70, it won't be good, but I'm also Buying some BAC 12.61-65 and all OILS. Too much negativity to not buy. Probably will retest lows, so it's a trade, but here are some t...

That is what I thought also, but statistics seem to point otherwise. Btw: becoming approval and becoming available may be two different things. Maybe the distribution networks are faster in EU?

I did a short study on the differences/similarities between drug approvals in Eu and US. I found a report (probably from 2014) that seems to provide an interesting overview. ===== State of US and Europe new drug product approvals in 2013 By Olga Björklund PhD, Senior Consultant, NDA Group Summary Wh...

This is what Leviek from SA recently said: 'The simple fact that opt-in by JNJ may come as soon as phase III MDS begins. If we get anything like the same percentage of TI's at Mayo, we're in. If they also decide to advance into AML phase 1, it may also trigger opt-in. I feel strongly that opt-in by ...

I have removed a couple posts now. Not too bad. We'll see how this board develops. Probably there will be more activity once there are new developments. Won't take too long, I guess. Whish Irish, sdrawkcabeman and a couple of others would start posting here. There are real good discussions on SA, bu...

Would be nice to know, though. Hoosier, Irish and others: any way to find out? I will do some research anyway.

Thanks for that, Bio. More often people say approval may go faster in the EU. How does that come? Are there any sources/statistics on that? And what about Asia?

Enterprise Leader (26 January, 2016): Geron Corporation (NASDAQ:GERN) Has Been Picked As A Growth Company Zacks Research has listed Geron Corporation (NASDAQ:GERN) in the group of firms, with a positive Growth Style Score. This analysis is reached after analyzing the firm’s growth potential and fina...

On SA I came across this nice overview (thanks to Whyted) of just good news since 2014: 01/23/16 MF NCT02426086 73 locations recruiting 38 Recruiting 01/23/16 MDS NCT02598661 51 locations 11 Recruiting 01/15/16 FBR & Co. Outperform target $6.00 01/14/16 Geron Corp (GERN) Doses First Patients in Phas...

Thanks for posting this update. Here are the links:
IMerge: https://clinicaltrials.gov/ct2/show/study/NCT02598661
IMbark: https://clinicaltrials.gov/ct2/show/study/NCT02426086

Everything is moving steadily. Is there any clue which may give an indication for when the AML trial starts this year?

(not new, but nice anyway...) Forefront, Mayo Clinic, Volume 4, issue 4, 2015 Researchers in the Mayo Clinic Cancer Center are studying a novel drug called imetelstat for the treatment of patients with myelofibrosis. Results of a Mayo Clinic study of the drug were published in the New England Journa...

Good promotion indeed. It shows confidence and that JnJ is taking imetelstat serious.

Thanks, Bio, also for your contributions. The fact that the CEO of the largest pharma on the globe mentions a not yet approved drug is quite remarkable. JnJ usualy is very cautious with communicating about early stage drugs. (note: they haven't send out press releases about IMbark or IMerge; that wa...

January 14, 2016 11:43 AM FBR Capital analyst Thomas Yip reiterated an Outperform rating and $6 price target on Geron Corporation (NASDAQ: GERN) after the company announced the first patient dosing in the Phase II/III IMerge trial of imetelstat in patients with myelodysplastic syndromes (MDS). "Whil...