Commsman's Pitch for IMBARK Phase 3 to the Geron Executive Management Team
Posted: Thu Apr 04, 2019 9:06 am
Greetings Imetelchat Community,
Thank you for providing this safe place to post ideas and communicate about all things Imetelstat! I have been very impressed by the quality of the information that I’ve found here. I have recently been inspired by kmall’s activist approach to this investment, so I’ve decided to get more active myself. I recently sent this message to Investor Relations at Geron, and I plan to share any response I get. I also look forward to feedback from Imetelchat’s very knowledgeable contributors.
Respectfully,
Commsman
Dear Geron Board and Executive Management Team,
I became a Geron Investor in March of 2018, though I made numerous investment purchases through July of 2018. I like to think many of my purchases went directly into them ATM offering, and therefore, Geron’s general fund. I would like to start by thanking John Scarlett and the Board of Directors for the professionalism and honesty in dealing with the investors. I have listened to each investor call and have found John Scarlett’s messages to be fair and prescient. I admit to being slightly impatient when Chip would talk so thoroughly about the plan IF JNJ elected not to continue the collaboration as I thought they would be foolish not to continue. However, I have been of the opinion since EHA in June of 2018 that Geron shareholders would gain far more value in Imetelstat if they got back 100% of the rights than they ultimately would from a continued collaboration with JNJ. When the discontinuation occurred, I remained confident that the science would ultimately prevail, and that Imetelstat is indeed a very promising treatment option for so many people with serious blood cancers. After the announced appointments of Dr Gutierrez and Dr Rizo, I nearly doubled my position in Geron with renewed confidence in Imetelstat’s future success.
I am more or less a regular Joe with no official background in Hematology or Oncology, but I have researched nearly everything I can on the development and clinical history of Imetelstat. I would like to propose or offer support for an option in the IMBARK trial. While I understand the strategic importance of creating a limited niche in the MDS indication, I think it would be a mistake to play an equally conservative card in the MF indication again. The strategy of “playing it safe” is already covered in IMERGE by treating highly transfusion dependent patients who are ESA relapsed/refractory and L & H naïve! This is a smart and wise path towards proving the value of Imetelstat to MDS patients. However, I think it would be strategically beneficial to use a more aggressive strategy with MF. Considering that the only approved therapy (Ruxolitinib), has well proven to only be a palliative measure at best, and in certain subsets has proven to bestow an increased risk to the patients, I would like to propose a phase 3 structure that could yield conclusive evidence as to whether Imetelstat should become an approved therapy option!
IMBARK Phase III - Head to Head Ruxolitinib vs. Imetelstat
Randomized Study of Treatment Naïve patients diagnosed with MF
Group 1 - Ruxolitinib only
Group 2 - Imetelstat only
Group 3 - Ruxolitinib + Imetelstat
One immediate benefit is that no patients would have the risk of getting no treatment in a placebo group. They would either get the standard treatment they would otherwise get without entering the trial, the experimental treatment that shows much promise in preventing disease progression, or both the standard and the experimental treatment. From all my research, it has become clear to me that many treatment options are needed by the doctors and patients. The next benefit is that this trial design would give Imetelstat 2 out of 3 paths to proving it is worthy of FDA approval, and Meatloaf always said “2 out of 3 ain’t bad!” Considering that data that shows imetelstat’s clear efficacy in ET and Dr Tefferi’s pilot study that included earlier stage MF patients who were Jakafi naïve, I am very confident that Imetelstat will show a clear advantage over just Jakafi alone – especially if an endpoint goal is to remain progression free.
My intentions with this suggestion are meant only in the most respectful way. Please bring this idea to the experts for consideration. I realize that the actual trial design has an enormous amount of complex factors that must be planned for, but I trust Dr. Rizo and team Geron to work out these crucial fine print details. I only hope that this basic concept for the framework can prove helpful as I believe it would be a very direct path towards uncovering truth through good science. I would be remiss if I failed to reveal that my Grandmother is currently living with MF, so this is a topic that is personal to me. I kindly thank you for reading my email and your consideration of these ideas. Please keep up the good fight!
Very Respectfully,
Commsman
XXX X XXX XX
Xxxxxxx XX XXXXX
xxx-xxx-xxxx
Independent Investor
Thank you for providing this safe place to post ideas and communicate about all things Imetelstat! I have been very impressed by the quality of the information that I’ve found here. I have recently been inspired by kmall’s activist approach to this investment, so I’ve decided to get more active myself. I recently sent this message to Investor Relations at Geron, and I plan to share any response I get. I also look forward to feedback from Imetelchat’s very knowledgeable contributors.
Respectfully,
Commsman
Dear Geron Board and Executive Management Team,
I became a Geron Investor in March of 2018, though I made numerous investment purchases through July of 2018. I like to think many of my purchases went directly into them ATM offering, and therefore, Geron’s general fund. I would like to start by thanking John Scarlett and the Board of Directors for the professionalism and honesty in dealing with the investors. I have listened to each investor call and have found John Scarlett’s messages to be fair and prescient. I admit to being slightly impatient when Chip would talk so thoroughly about the plan IF JNJ elected not to continue the collaboration as I thought they would be foolish not to continue. However, I have been of the opinion since EHA in June of 2018 that Geron shareholders would gain far more value in Imetelstat if they got back 100% of the rights than they ultimately would from a continued collaboration with JNJ. When the discontinuation occurred, I remained confident that the science would ultimately prevail, and that Imetelstat is indeed a very promising treatment option for so many people with serious blood cancers. After the announced appointments of Dr Gutierrez and Dr Rizo, I nearly doubled my position in Geron with renewed confidence in Imetelstat’s future success.
I am more or less a regular Joe with no official background in Hematology or Oncology, but I have researched nearly everything I can on the development and clinical history of Imetelstat. I would like to propose or offer support for an option in the IMBARK trial. While I understand the strategic importance of creating a limited niche in the MDS indication, I think it would be a mistake to play an equally conservative card in the MF indication again. The strategy of “playing it safe” is already covered in IMERGE by treating highly transfusion dependent patients who are ESA relapsed/refractory and L & H naïve! This is a smart and wise path towards proving the value of Imetelstat to MDS patients. However, I think it would be strategically beneficial to use a more aggressive strategy with MF. Considering that the only approved therapy (Ruxolitinib), has well proven to only be a palliative measure at best, and in certain subsets has proven to bestow an increased risk to the patients, I would like to propose a phase 3 structure that could yield conclusive evidence as to whether Imetelstat should become an approved therapy option!
IMBARK Phase III - Head to Head Ruxolitinib vs. Imetelstat
Randomized Study of Treatment Naïve patients diagnosed with MF
Group 1 - Ruxolitinib only
Group 2 - Imetelstat only
Group 3 - Ruxolitinib + Imetelstat
One immediate benefit is that no patients would have the risk of getting no treatment in a placebo group. They would either get the standard treatment they would otherwise get without entering the trial, the experimental treatment that shows much promise in preventing disease progression, or both the standard and the experimental treatment. From all my research, it has become clear to me that many treatment options are needed by the doctors and patients. The next benefit is that this trial design would give Imetelstat 2 out of 3 paths to proving it is worthy of FDA approval, and Meatloaf always said “2 out of 3 ain’t bad!” Considering that data that shows imetelstat’s clear efficacy in ET and Dr Tefferi’s pilot study that included earlier stage MF patients who were Jakafi naïve, I am very confident that Imetelstat will show a clear advantage over just Jakafi alone – especially if an endpoint goal is to remain progression free.
My intentions with this suggestion are meant only in the most respectful way. Please bring this idea to the experts for consideration. I realize that the actual trial design has an enormous amount of complex factors that must be planned for, but I trust Dr. Rizo and team Geron to work out these crucial fine print details. I only hope that this basic concept for the framework can prove helpful as I believe it would be a very direct path towards uncovering truth through good science. I would be remiss if I failed to reveal that my Grandmother is currently living with MF, so this is a topic that is personal to me. I kindly thank you for reading my email and your consideration of these ideas. Please keep up the good fight!
Very Respectfully,
Commsman
XXX X XXX XX
Xxxxxxx XX XXXXX
xxx-xxx-xxxx
Independent Investor