How’s this for a five year perspective?

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How’s this for a five year perspective?

Post by biopearl123 » Mon Apr 17, 2023 10:05 pm

This letter was brought out of the archives by Karazogoglu and brought to my attention. He and I agree the board might find it interesting:

Dear Dr. Scarlett:

This letter reflects collaboration and input via a large cross-section of investors and patients using the various social media platforms including, Seeking Alpha, Twitter, Facebook and the Yahoo Geron message board. Many have collaborated and contributed to this inquiry in hopes of being provided answers to the issues that have been troubling us for some time and have not been addressed adequately in your conference calls to investors and analysts. Many of us, your company’s retail investors suffered staggering losses in the aftermath of the JNJ/Janssen decision. Yet we continue to maintain a vested interest in Geron’s success in commercializing Imetelstat and delivering Imetelstat to the thousands of patients desperately in need of its proven effectiveness.

Please share your detailed responses to the following six questions with us or you prefer with the investor community at large as appropriate in the upcoming official forums. We believe your cogent answers to these will help reduce the investor uncertainty and go a long way to restore our confidence in Geron’s success.

1) The inquiries about the inclusion of Imetelestat in Janssen’s

compassionate use list had been answered by Janssen officials as

“administrative error”. Many of us find that explanation inadequate on

several levels, especially timing as it led many investors to cheer this as

a pivotal signal JNJ/Janssen would make a positive continuation decision.

Similarly, the job postings made by Janssen on planning and pricing for

Imetelstat was apparently made in error in the same timeframe. The job

postings were also interpreted both as an impending positive continuation

and likely action related to drug approval. Again the investors and patients

alike were guided due to these actions.

Certainly the Geron / Janssen joint steering committee (JSC) must have been involved, can you explain how something so significant and impactful could have occurred in error given Geron’s involvement and oversight via the JSC?

2) 30 months MOS in the IMbark clinical trial (CT) along with the other

improvements appear so astounding as immediate accelerated approval seems straightforward without a Phase III trial. Consider the track record of MOS in FDA approved drugs. Avastin had received

accelerated approval in 2008 after a study showed it improved survival by

5.5 months over chemotherapy alone in breast cancer patients. Article

published in USA today states most cancer drugs approved by FDA do little to improve survival: ... /97712858/

Will accelerated approval or any other advanced designation be included in your discussions with the FDA in 1Q2019 and what are the constraints that seem to be delaying any action in this space until the end of 3Q2019?

3) The length of time to transfer the intellectual property and trials back

to Geron appears very conservative at best. We believe every effort should be made to speed the transfers up in light of the ethical and financial implications; these critical factors cannot be avoided. It is of major concern that patients are not receiving Imetelstat and dying in waiting. Likewise, delays in obtaining revenue streams necessary for sustaining Geron are critical as well.

Given the competitive landscape along with the ethical and financial

considerations, what management tools and actions have you put in place to facilitate accelerating the transfer processes?

4) There appears to be obvious advantages of having a partner(s) with strong financial support and experience available now. Significant time and expense could be saved by having the partner help accelerate and receive the transfer of the trials across both both companies’ R&D organizations, etc., versus reintegrating with the partner in an entirely unrelated second phase later in the year.

Why is it necessary to delay seeking a partner until after the transfer of

the trials, etc.?

5) Given the outstanding CT results presented at the 2018 ASH conference, the reasons for JNJ/Janssen’s negative decision does not appear to be data related but rather something else such as regulatory feedback and / or revenue outlook possibly based on patient numbers or commercialization delays. J&J’s brief official statement regarding their decision to end the partnership had not alleviated investor concerns. Uncertainty regarding this issue is weighing heavily on investor confidence.

If you can add any detail beyond J&J’s statement, this would be immensely helpful. What specific plans are you considering restoring investor confidence, which was shattered following JNJ/Janssen’s negative continuation decision?

6) Lastly, could you elaborate on if you are / are not seeking out

assistance from benign investor or medical activists to assist you / Geron

navigate the challenges in both the financial and FDA/EUA environments,

including the names of these organizations?

Thank you kindly,

A group of Geron Investors with high stakes

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