"We have gotten positive feedback"
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- Back up claims with evidence/reasoning/sources (posting links is allowed)
- No commercials/harassment/spam
"We have gotten positive feedback"
I do wish Dr. S would just tell us something substantial. Our CEO toys with us. The "we have gotten positive feedback" comment could mean anything. "We have gotten positive feedback about how nice our staff is or how the protocol is easy to read." No. Dr. S is not a fool. He means to telegraph that positive feed back from research sites means the drug is doing what is it supposed to do. But we know that from Dr. Teferri. Nothing new from this conference. I even doubt news of the AML protocol will be our gift at the yearly May meeting. The guy has got to throw us a bone. But but he seemed to indicate that they weren't even sure about what combo drug they would use... at this late point!!??? Waiting for news until mid 2017 seems excessive. Usually there is something to keep stringing along stockholders. Is anyone going to the annual meeting in Calif? If you are can you ask about the status of the myeloma trial or the pediatric brain tumor trials? Also I still seek information about the two PV patients in Dr. T's study. I am starting to reluctantly line up with the we will be acquired group since the approach from Menlo Park seems to be deliberate obfuscation. Regards, bp
Re: "We have gotten positive feedback"
Or EU approval?
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Fishermangents
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Re: "We have gotten positive feedback"
Bio, I understand your frustration, if I may call it like that. The problem is that we don't oversee all that is going on. Given the progress on the recruitment, the expanding of the number of sites, and with the 'positive feedback from the investigators' we can only assume that things are going well behind the screens, whatever that means. And maybe - I think probably - big things are about to happen. Maybe not tomorrow, so I don't expect something on the short term. Although, any form of fast track could catch is by surprise. Yes, the silence is agonizing, I agree. We can't do otherwise than trust the signs we have got and which are still pointing in the right direction already for almost 2 years! It is matter of personal style and judgement whether it takes too long to wait or not. I can wait, and I will.
Re: "We have gotten positive feedback"
Great posts. I have emailed Geron a couple times re MM trials, and not received any response, not surprised. The following is posted on the Geron Website re May 17, 2016 call:
Geron stockholders accessing the annual meeting by telephone will be invited to ask a question during the question and answer session. Geron stockholders may also submit a question in advance of the meeting by emailing AnnualMeeting2016@geron.com.
Apparently someone on SA tried to ask a question at the May 5 Qtr1 call and was unable to get on. Not sure why, but I do recall instructions saying to call at least 10 minutes prior to start in order to get in queue.
Geron stockholders accessing the annual meeting by telephone will be invited to ask a question during the question and answer session. Geron stockholders may also submit a question in advance of the meeting by emailing AnnualMeeting2016@geron.com.
Apparently someone on SA tried to ask a question at the May 5 Qtr1 call and was unable to get on. Not sure why, but I do recall instructions saying to call at least 10 minutes prior to start in order to get in queue.
Re: "We have gotten positive feedback"
Good info. Fish you are right, it was the wine speaking (a great bottle of Quintessa). Fish, hip brings up an interesting opportunity namely to submit a question to Dr. S et al.. They will probably screen the questions and be opaque but Fish, would you take the lead and let all submit questions to each other and then assign interested individuals to submit single questions to the meeting? That way we can cover as many bases as possible and not risk overlap or the possibility they will ignore a long list of questions, we could each just ask a single question. E.G.:
1. Why has the information on the two PV patients in the ET study not been made public (when PV was in the title of the study along with ET).
2. Can you update us on the myeloma study and are any further publications anticipated?
3. What is the status of the Pediatric Consortium study?
4. Do you anticipate submission to the EU for approval in MF before submission to the FDA?
5. What is the current enrollment status of the ongoing studies.
I think we can couch the questions in polite terms and hope for substantive responses. Thoughts?
1. Why has the information on the two PV patients in the ET study not been made public (when PV was in the title of the study along with ET).
2. Can you update us on the myeloma study and are any further publications anticipated?
3. What is the status of the Pediatric Consortium study?
4. Do you anticipate submission to the EU for approval in MF before submission to the FDA?
5. What is the current enrollment status of the ongoing studies.
I think we can couch the questions in polite terms and hope for substantive responses. Thoughts?
Re: "We have gotten positive feedback"
Ok since there were no takers here's what I submitted to the annual meeting (hat tip to hip rock for the email address).
I have been a stock holder since the beginning of Geron and am pleased to see the direction and leadership finally provided by Dr. Scarlett. I thank you for the opportunity to ask a few questions of the company leadership during the meeting. As I will be working I may not be able to ask on the phone. Thank you for allowing this.
1. Are patients still enrolled and receiving treatment in the myeloma study?
2. Can you disclose data on the two PV patients enrolled in the pilot study? If not what was the rational for not sharing this data since the patients were enrolled in a study that included PV as part of its focus (given the eponymous title of the study?)
3.. Can we anticipate disclosure of data from the Pediatric Consortium study?
4. Are the Janssen studies in PV and MDS designed to facilitate approval in the EU given the number of non US sites chosen and what kind of timeline might be reasonable to expect?
My best wishes for Geron’s success. (Name withheld from this board but submitted to Geron).
I have been a stock holder since the beginning of Geron and am pleased to see the direction and leadership finally provided by Dr. Scarlett. I thank you for the opportunity to ask a few questions of the company leadership during the meeting. As I will be working I may not be able to ask on the phone. Thank you for allowing this.
1. Are patients still enrolled and receiving treatment in the myeloma study?
2. Can you disclose data on the two PV patients enrolled in the pilot study? If not what was the rational for not sharing this data since the patients were enrolled in a study that included PV as part of its focus (given the eponymous title of the study?)
3.. Can we anticipate disclosure of data from the Pediatric Consortium study?
4. Are the Janssen studies in PV and MDS designed to facilitate approval in the EU given the number of non US sites chosen and what kind of timeline might be reasonable to expect?
My best wishes for Geron’s success. (Name withheld from this board but submitted to Geron).
Re: "We have gotten positive feedback"
Thanks for submitting these questions to Geron; they're crafted very well, and hopefully Dr. Scarlett will respond.
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Fishermangents
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Re: "We have gotten positive feedback"
Hi Bio, thanks for your action. Sorry for not having responded earlier (I was busy outdors). I may add these questions:
1)
- Are you aware of JNJ having shifted the anticipated IMbark completion date by moving it with one year from 2019 to 2018?
- If so: what have been the rationale for that?
- Does this earlier completion date also involve some kind of accelerated approval process?
2)
- It seems that the expansion and activitation of sites in Europe is going fast. Is it possible we may see approval in Europe first before the US?
I will submit these questions today.
1)
- Are you aware of JNJ having shifted the anticipated IMbark completion date by moving it with one year from 2019 to 2018?
- If so: what have been the rationale for that?
- Does this earlier completion date also involve some kind of accelerated approval process?
2)
- It seems that the expansion and activitation of sites in Europe is going fast. Is it possible we may see approval in Europe first before the US?
I will submit these questions today.
Re: "We have gotten positive feedback"
The question I have for the good doctor relates to "what's next" for Imetelstat. Any ideas on how to phrase the question for the best chance of response would be appreciated. I was reviewing an interview of Dr. Gryaznov, former employee of Geron by drkkd.com:
"Dr. Gryaznov held the positions of Director of Nuclear Acidic Chemistry and Senior Research Fellow at Geron Corporation, with responsibility for the design and discovery of novel anticancer agents, including inhibitors of human telomerase (ImetelstatTM a.k.a. GRN163L)
if it would be my company to run, I’d emphasize
a) Second generation and back-ups for GRN163L with better therapeutic index
b) Potent and unique oligonucleotide chemistry platform, (there is no of a such platform anywhere else) which allows to target many more cancers via telomerase, telomeres, etc, as well as non-telomerase targets in cancer
c) Small molecule telomerase and telomere targeting compounds in cancer, with novel/distinct mechanism of actions vis-à-vis GRN163L"
My hope is this is exactly what J&J is working on.
"Dr. Gryaznov held the positions of Director of Nuclear Acidic Chemistry and Senior Research Fellow at Geron Corporation, with responsibility for the design and discovery of novel anticancer agents, including inhibitors of human telomerase (ImetelstatTM a.k.a. GRN163L)
if it would be my company to run, I’d emphasize
a) Second generation and back-ups for GRN163L with better therapeutic index
b) Potent and unique oligonucleotide chemistry platform, (there is no of a such platform anywhere else) which allows to target many more cancers via telomerase, telomeres, etc, as well as non-telomerase targets in cancer
c) Small molecule telomerase and telomere targeting compounds in cancer, with novel/distinct mechanism of actions vis-à-vis GRN163L"
My hope is this is exactly what J&J is working on.