ImetelChat

Published on: August 04, 2016 (WASHINGTON, August 4, 2016) The American Society of Hematology (ASH) will recognize J. Evan Sadler, MD, PhD, of Washington University School of Medicine in St. Louis, and Ayalew Tefferi, MD, of Mayo Clinic College of Medicine, with the 2016 Henry M. Stratton Medal for ...

Here a post from Sdrawkcabeman (Yahoo MB, yesterday): Some thoughts on the call. I hope no one was expecting anything new, since we’ve all known the next development was going to be after the internal reviews. Dr. S was reticent as always but keep in mind that Janssen is the sponsor for all relevant...

AML I checked the Q2 telco again and at the end Dr.Scarlet said that regarding AML there were no upates. So he reiterated wat has said about that earlier. So no change of plan. Off course it is now clear that it won't be single a agent trial but a combo. He said that at the Mayo trial they gave som...

As long there is no bad news I keep confident. Two things from the call: - confirmation of the 30 and 40 enrolment completion: that is important indeed, because we now we can start counting the days, although we don't know when exactly the enrolment was completed. It can be added as a fact to the Li...

The AML study has been anounced various times during all the recent calls and meetings where Dr. Scarlet spoke. Apart from this last Q2 call. After so many announcements this can't just evaporate. It would be a major change of plan. We have still a couple of months to go in 2H 2016, so it is too ear...

Hunt, I certainly believe that studies that haven't continued (for whatever reason) are an important source of information to JnJ and Geron. This all contributes to getting a better picture of the workings of imetelstat in human biology. Choices on which disease to target next and how (single vs com...

Bio, I think there can be more explanations for not making the results public. You're probably right in thinking that the results were not spectaculary positive. But they also don't need to be negative either. There can be various reasons for not publicizing. It can be that they don't exaclty know t...

Great article. Thanks, Cheng. Next to the high tech content there is a nice overview on clinical experiences with imetelstat: "Imetelstat has been extensively evaluated for its activity and efficacy against multiple cancer cell lines and in mouse xenograft models in preclinical studies. Imetelstat d...

Bio, guess you're right.

Bio, I saw this report also recently. The full title is: A molecular biology and phase II study of imetelstat (GRN163L) in children with recurrent or refractory central nervous system malignancies: a pediatric brain tumor consortium study. link: http://www.ncbi.nlm.nih.gov/pubmed/27350411 Imetelstat...

Cheng: that would create unacceptable risks for patients who may take uninformed decisions out of desperation.

Running an early biotech is a piece of cake....

MENLO PARK, Calif., July 27, 2016 (GLOBE NEWSWIRE) (Nasdaq:GERN) will announce its financial results for the second quarter ended June 30, 2016, on Wednesday, August 3, 2016, after the market close. Geron’s management will also host a conference call for analysts and investors on Wednes day, August ...

Bio, ODD decision making is separate from the decision making on market authorization. The only thing the ODD Committee does is earmarking certain drugs as an orphan drug (serious disease, small patient population, no good drug avaiable). Once in a while they check if the drug is still ODD-valid. Ma...

Bio, in Article 3 sub 2 of (EC) No 507/2006 it says: "The Committee for Medicinal Products for Human Use, hereinafter ‘the Committee'" So everytime you see 'the Committee' in this document it refers to 'The Committee for Medicinal Products for Human Use'. That committee that also decides on regular ...

So I checked the EU Regulation (EC) No 507/2006 dealing with Conditional Marketing Approval (CMA). To start with the question: does imetelstat meet with the basic criteria for CMA and therfore: is it reasonable to think that Geron/JnJ has applied for CMA? The regulation says: Aricle 2 - Scope This R...

The problem I have is that we don't know if Geron/JnJ have applied for some kind of fast track as we speak. I suppose they will not announce it when they do the application. We will only know about it when the decision has been taken, positive or negative. Maybe we will never know a negative decisio...

The EMA currently has two procedures to speed up to path of a new drug to the patients: Accelerated assessment EMA’s accelerated assessment procedure allows for a faster assessment of eligible medicines by EMA’s scientific committees. Rapid assessment of medicines in the centralised procedure that a...

Btw: what we could do is the create a subforum and start a thread for each of the fast track procedures as soon this thread becomes too busy and needs better organisation of topics and responses.

Hunt, this is a great call. I grant my support to your plan. It can be a thread (like this one) or even a seperate forum within ImetelChat. Maybe start with a thread. The point you raise is very true. At the same time the people at EMA and FDA do share your vision. That's why I have the feeling that...