Stratego..........

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kmall
Posts: 753
Joined: Thu Mar 21, 2019 3:57 pm

Stratego..........

Post by kmall » Tue Feb 15, 2022 3:54 am

A poster on the YMB recently questioned Dr. Scarlett's "strategic plan," even going so far as suggesting that Dr. Scarlett has been "winging it to see what happens" these past 3+ years. Normally I wouldn't bother reposting another person's post on Imetelchat, however, Andrew-bp suggested posting my reply here. Just for reference and to put into context some of the nonsensical thinking which occurs on many other boards concerning Geron/Imetelstat, I have decided to include the following. With full credit for the following post going to none other than the prolific.......

BLACKMARANGO 11 hours ago
$GERN conversation
As I was perusing the threads this morning, I discovered an interesting notion which may help explain many of chippy's failures!

Maybe, just Maybe chippy does NOT have a GERN Strategic Plan with specific operational detail?!?!? Maybe it's all just top detail that's vague enough to allow no structure and maximum flexibility as he rides the golden carpet into retirement?

Charts shown at the various conferences, CCs, etc. are mostly the same with few operational details!

Could it be that chippy's REAL strategy is just to "wing it" and see what happens? Something fails (Janssen Walks), make a sharp right turn and develop your own testing plan using several years as a program buffer?

Something to think about as we watch the GERN paint dry!

Of course, IMO.
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And now my reply.......

kmall 5 hours ago
@BLACKMARANGO........no strategic plan ??? You obviously haven't been paying attention.......try reading this...........


1. Two Phase 3 Clinical Trials.........one nearing completion, the other gaining full enrollment momentum with various locations on FIVE continents.

2. Three physical locations to handle facility operations and regulatory submissions in 2 countries.

2a. USA - West Coast/CA - Facility/Legal/Manufacturing - Foster City, CA - in the heart of emerging Biotechs.

2b. USA - East Coast/NJ - Clinical/Business/UK support - Parsippany, NJ - in the heart of Big Pharma USA Headquarters - JNJ, Pfizer, Novartis, and a litany of other BP are within a 100mile radius of Geron's satellite location.

2c. UK - Altrincham, England - Regulatory/EU and UK Submission Team/Supply Chain - within 30min or so of NICE location in Manchester -
National Institute for Health and Care Excellence
Level 1A, City Tower
Piccadilly Plaza
Manchester

3. Three additional P1 - P1/2 Clinical Trials expected to begin in less than 5 months, with one additional indication (AML) and two combos.

4. Lymphoid Malignancies CURRENTLY being studied in pre-Clinical at MD Anderson Cancer Center - one of the world's most - if not THE MOST prestigious Cancer Research Hospital/Facility. Imetelstat has been studied in Lymphoma previously by none other than Dr. Rizo - CMO Geron Corporation.

5. ILAP Innovation Passport granted in the UK with an expedited pathway to approval in the UK.

6. Australia has been chosen for a Clinical Trial location of P1 IMpress – the Investigator sponsored new clinical program to evaluate Imetelstat as a single agent in higher risk MDS and acute myeloid leukemia (AML).

Australia’s Regulatory Agency - Therapeutic Goods Administration (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.”

Australia 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).

6a. 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.

6b. 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: provisional determination, pre-market registration, the provisional registration period, extension of provisional registration and transition to full registration.

*** I could go on and on, with the team Dr. Scarlett has assembled, not to mention manufacturing and strategic business processes Geron has or is beginning to implement. It doesn't really get any more strategic than what Dr. Scarlett has managed to accomplish with this current team in place and on-going Clinical Trial Design's. -Kmall

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I have no intention of trying to turn this board into the next YMB. For that reason, I have edited my reply slightly to fall more in line with the quality of input expected here. -Kmall

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