multiple myeloma ?

[rccola335]

https://bnnbreaking.com/world/australia ... le-myeloma

[rccola335]

i am replying to my own post if this is allowed - where did the multiple myeloma come from? is this from Dr Lane (article from australia) - is it easier to try things there vs US or Europe? I think a lot of things are going on that we do not know about

[kmall]

RC - not sure if this is exactly the answer you're looking for or if this pertains to your post, but Australia has it's own equivalent to the FDA known as the TGA (Therapeutic Goods Administration). I posted an in-depth post about the pathways to approval which are similar to the UK's MHRA.

https://www.tga.gov.au/#:~:text=Therape ... f%20Health



This post is from 2yrs ago........

http://imetelchat.imetelstat.eu/viewtop ... f=1&t=1260


"For those interested, Australia’s Regulatory Agency (TGA), has a similar structure to that of the UK with expedited pathways for approval in novel, rare disease, unmet needs, and promising new medicines in which “the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.” (see below – Provisional Approval Pathway)

Australia’s Regulatory Agency: Therapeutic Goods Administration (TGA)
https://www.tga.gov.au/australian-regul ... l-products
has a process similar to that of the EMA and FDA, including Registration, Application for Approvals, Data Submission, Orphan Drug Designation, as well as a Priority review pathway and Provisional approval pathway through the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
https://www.tga.gov.au/publication/aust ... ines-argpm

Priority review pathway: The priority pathway provides a formal mechanism for faster assessment of vital and life-saving prescription medicines. The target timeframe of 150 working days is up to three months shorter than the standard prescription medicines registration process.
https://www.tga.gov.au/priority-review- ... -medicines

Sounds familiar to the UK ILAP Innovation Passport which Imetelstat was granted on 10/25/2021:
https://ir.geron.com/investors/press-re ... fault.aspx

Provisional approval: The provisional approval pathway allows sponsors to apply for time-limited provisional registration on the Australian Register of Therapeutic Goods (ARTG). It provides access to certain promising new medicines where we assess that the benefit of early availability of the medicine outweighs the risk inherent in the fact that additional data are still required.
Provisional registration of prescription medicines under this pathway is limited to a maximum of six years. Registration will automatically lapse at the end of a specified period unless sponsors are able to demonstrate that they have met the conditions imposed on the provisional registration. Sponsors may apply for full registration when sufficient clinical data to confirm the safety and efficacy of the medicine are available.
The Provisional approval pathway consists of five steps as outlined in the Provisional approval diagram [see right]: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.
https://www.tga.gov.au/provisional-appr ... -medicines

At this time Geron has not applied for either of these pathways or an application through the TGA – to the best of my knowledge. These links are provided for information and dialog purpose only."

*Personally I would have preferred Geron pursued one of the smaller global Regulatory Agencies like the MHRA or the TGA before the FDA or EMA. -Kmall

[biopearl123]

RC, you come up with some pretty pretty good stuff! And Kmall, thank you again for all of the important contributions you make to this board. Re MM: There is not active study investigating MM, at least in the public domain. This could be a well meaning journalist who did not dig deeply enough or it is an excellent journalist who dug very deeply indeed and came up with gold. Hard to know. What we do know is that Geron did study MM about a decade ago and found a reduction in the circulating MM stem cell. They did not pursue it for, why? We do not know. It would be outstanding if MM could be revisited and investigated. Thanks for posting this potential find. Regards to all, bp

[biopearl123]

RC, of course it’s ok to answer your own posts, I seem to do it all the time! In thinking about this I think this article represents an understandable confusion on the part of the journalist. The distinction between MM, AML, various other hematopoietic disorders is hard enough for us to keep straight, and we work at it almost every day. I can see a well meaning journalist make an honest mistake. I suspect the article referred to the recent AML/feroptosis work from Dr. Lane’s lab.

[kmall]

Bp - that's what I was thinking.

[rccola335]

I was thinking the same - they were told there was a promising drug for heme malignancies named imetelstat and they assumed for MM - now the Geron job posting for sales reps says for heme malignancies and not just MDS and MF - i think we can expect imetelstat will be used for PV ET MDS and a good chance for MF - reasonable chance for AML and high Risk MDS - just need to get MDS approved and off to the races