Search found 23 matches
- Mon Aug 05, 2019 8:18 pm
- Forum: ImetelChat
- Topic: New Hires Continue
- Replies: 2
- Views: 4423
Re: New Hires Continue
Director, Drug Substance (API) Manufacturing https://www.linkedin.com/comm/jobs/view/1404133083?alertAction=markasviewed&savedSearchAuthToken=1%26AQGHdOmPKaeLfAAAAWxi5UccuNLQFULgUn2NvVSUv-6qm-28sIeFQJ4uAdpw8rybP8JN7pX7dnQhsHr54oRk_UzmZc1xMPgWEMjNbDj0TOzd6bKdqBOvpzy4avH966QbzbtT_k-QnRQ5Jwpasp4IFVuCUc...
- Wed Jul 31, 2019 9:12 pm
- Forum: ImetelChat
- Topic: New Hires Continue
- Replies: 2
- Views: 4423
Re: New Hires Continue
Associate Director / Regulatory Affairs https://www.linkedin.com/comm/jobs/view/1393446010?alertAction=markasviewed&savedSearchAuthToken=1%26AQEmK-3jFSU3cAAAAWxJLWRkQplpqLm3l6WaU6ye-cHMXJvEka5EXObaXbNVlXhO9shnAw647E3oXTrI5Om1suvgWgtKlUOetoa9HiVBFiDqgMhOfTbwQX0LwGJmcxzo8T7Q_roM4YXO9fbuCuUais5-ZGgXVW3...
- Mon Jul 29, 2019 7:04 pm
- Forum: ImetelChat
- Topic: Janssen Patent Application
- Replies: 3
- Views: 4296
Janssen Patent Application
Just came across this patent application (http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=9&f=G&l=50&co1=AND&d=PG01&s1=imetelstat&OS=imetelstat&RS=imetelstat) from Janssen dated January 31, 2019 (sorry if this is not new here). The timin...
- Fri Jan 18, 2019 10:02 pm
- Forum: ImetelChat
- Topic: iMbark - Extension Phase Extended
- Replies: 1
- Views: 2819
iMbark - Extension Phase Extended
The study status and study description for the iMbark trial on clinicaltrials.gov was updated today to add a year to the extension phase to continue monitoring for overall survival and adverse events:
https://clinicaltrials.gov/ct2/history/ ... 2&C=merged
https://clinicaltrials.gov/ct2/history/ ... 2&C=merged
- Thu Sep 20, 2018 3:36 am
- Forum: ImetelChat
- Topic: Why Imbark gets approved
- Replies: 7
- Views: 8844
Re: Why Imbark gets approved
Timely question. Janssen is certainly willing to try: https://www.janssen.com/janssen-submits-new-drug-application-us-fda-seeking-approval-erdafitinib-treatment-metastatic "HORSHAM, Pa., Sept. 18, 2018 -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New D...
- Wed Sep 19, 2018 6:26 pm
- Forum: ImetelChat
- Topic: Why Imbark gets approved
- Replies: 7
- Views: 8844
Re: Why Imbark gets approved
Regarding the effectiveness of various doses of imetelstat, I have been impressed with the responses of the MDS patients, for example, as shown on Slide 11 of the EAH presentation from June ( https://www.geron.com/file.cfm/53/docs/Imetelstat-IMergePart1-EHA-2018.pdf ). The dot represents a dose of 7...
- Mon Sep 17, 2018 4:34 pm
- Forum: ImetelChat
- Topic: The OTHER Janssen Agreement
- Replies: 2
- Views: 5472
The OTHER Janssen Agreement
As is common knowledge, Janssen and Geron have a second license agreement signed following the imetelstat collaboration agreement. Janssen licensed additional patents and rights from Geron to develop new drugs outside the field of telomerase inhibition. The agreement provides for annual license fees...
- Fri Sep 14, 2018 4:46 pm
- Forum: ImetelChat
- Topic: Ongoing Trial Updates
- Replies: 6
- Views: 6060
Re: Ongoing Trial Updates
Just a minor curiosity item ... the study status for the withdrawn GRN1005 study in brain metastases from breast or lung cancer continues to be updated quite regularly:
https://clinicaltrials.gov/ct2/history/NCT01679743
I'd love to know what that's all about.
https://clinicaltrials.gov/ct2/history/NCT01679743
I'd love to know what that's all about.
- Tue Aug 28, 2018 11:03 pm
- Forum: ImetelChat
- Topic: Upcoming Catalysts
- Replies: 5
- Views: 11001
Upcoming Catalysts
It's been a long quiet period up until the past few days but there are a number of catalysts on the horizon. Here's a quick list of what I anticipate to be the many potentially market-moving events for GERN in the coming weeks and months: 1. 9/13 – JNJ Pharmaceutical Business Conference Call 2. 9/13...
- Thu Aug 23, 2018 8:39 pm
- Forum: ImetelChat
- Topic: Ongoing Trial Updates
- Replies: 6
- Views: 6060
Re: Ongoing Trial Updates
I had not considered the "right to try" or compassionate use as a possible explanation. That would be very compelling.
- Thu Aug 23, 2018 4:23 pm
- Forum: ImetelChat
- Topic: Ongoing Trial Updates
- Replies: 6
- Views: 6060
Re: Ongoing Trial Updates
The study status for GRN1005 was updated again yesterday.
https://clinicaltrials.gov/ct2/history/ ... 5&C=merged
Very curious.
j6p
https://clinicaltrials.gov/ct2/history/ ... 5&C=merged
Very curious.
j6p
- Tue Aug 21, 2018 12:19 am
- Forum: ImetelChat
- Topic: Ongoing Trial Updates
- Replies: 6
- Views: 6060
Ongoing Trial Updates
One of the aspects of the current status of imetelstat's evolution that is so curious to me is the ongoing updates to all of the clinical trials, not just IMbark and IMerge. There was an update on August 7 on an old trial evaluating imetelstat in younger patients with relapsed or refractory solid tu...
- Fri Aug 17, 2018 6:15 pm
- Forum: ImetelChat
- Topic: New Patent / IMET 2.0 ?
- Replies: 3
- Views: 4105
Re: New Patent / IMET 2.0 ?
There was a second patent issued to Geron on July 31 that I overlooked: m Synthesis of protected 3'-amino nucleoside monomers Abstract Orthogonally protected 3'-amino nucleoside monomers and efficient methods for their synthesis are described. The methods employ selective protection of the 3'-amino ...
- Mon Aug 13, 2018 7:44 pm
- Forum: ImetelChat
- Topic: New Patent / IMET 2.0 ?
- Replies: 3
- Views: 4105
New Patent / IMET 2.0 ?
A new patent was issued to Geron on July 31, 2018, relating to compounds useful in inhibiting telomere elongation. See: https://tinyurl.com/y976ctrh (link to USPTO patent). I've yet to review and would welcome comments from others who do.
Best regards,
j6p
Best regards,
j6p
- Thu Aug 02, 2018 5:15 am
- Forum: ImetelChat
- Topic: An excellent article by Hoosier Investor on SA
- Replies: 7
- Views: 12039
Re: An excellent article by Hoosier Investor on SA
A postscript:
GERN is confident the continuation decision will be coming in Q3. One way to have such confidence is to know the FDA has a PDUFA decision date prior to September 30, if JNJ has submitted its NDA application. Just thinking out loud.
j6p
GERN is confident the continuation decision will be coming in Q3. One way to have such confidence is to know the FDA has a PDUFA decision date prior to September 30, if JNJ has submitted its NDA application. Just thinking out loud.
j6p
- Wed Aug 01, 2018 8:29 pm
- Forum: ImetelChat
- Topic: An excellent article by Hoosier Investor on SA
- Replies: 7
- Views: 12039
Re: An excellent article by Hoosier Investor on SA
My current theory is that JNJ has applied for accelerated approval for MF based on the primary analysis of IMbark and needs the FDA's decision in order to present GERN with a clinical development plan. In other words, JNJ needs to know if a future registration study is still needed for MF or if IMba...
- Wed Jul 25, 2018 6:54 am
- Forum: ImetelChat
- Topic: Look for the Continuation Decision next week
- Replies: 3
- Views: 5232
Re: Look for the Continuation Decision next week
I share your opinion that I expect the continuation decision in the near future. This week will be three full months since the primary analysis began for IMbark. We know that Janssen has to complete the primary analysis and also submit a clinical development plan for Geron's consideration of whether...
- Fri Jul 20, 2018 3:58 pm
- Forum: ImetelChat
- Topic: Mayo Study Complete
- Replies: 0
- Views: 4150
Mayo Study Complete
Janssen updated the ClinicalTrials.Gov site for the Mayo study today to change the status from "Active, Not Recruiting" to "Complete" with a completion date of May 24, 2018. m Interestingly, results were posted today to a separate study of imetelstat conducted by the Pediatric Br...
- Wed Jul 18, 2018 7:34 pm
- Forum: ImetelChat
- Topic: FDA Thoughts on Accelerated Approval
- Replies: 6
- Views: 8862
FDA Thoughts on Accelerated Approval
I found these articles to be of interest with respect to the FDA's approach to supporting accelerated approvals of single-arm studies that do not include a placebo/control arm. The articles are authored/co-authored by Gideon Blumenthan, MD, who is the Deputy Director (acting) of the Office of Hemato...
- Mon Jul 16, 2018 9:30 pm
- Forum: ImetelChat
- Topic: New Patent Includes Imetelstat
- Replies: 2
- Views: 4965
New Patent Includes Imetelstat
Novartis was issued a patent last week for a new molecular entity that inhibits tankyrase, which can have a cascading effect on temolere access to telomerase. The patent is for Novartis's NME but includes its use in combination with other drugs, including imetelstat: http://patft.uspto.gov/netacgi/n...