Geron Corp (GERN)

[Joda]

from yahoo board...

Everyone is looking for "hold lifted" and not "IND transferred". Makes the "hold lifted' discussion now null and void. I deem from this point forward no Geron long ever mention the word "hold" again. Geron owns a nice new hold-free IND to use for Phase II. If you research "IND Transfer" (Emory University clinical trial site has nice summary), you will say "why didn't I think of that (me either!). God bless Mayo and Dr. Tefferi.

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it is no longer Mayo's IND. It is Geron's ID. Per the public announcement, Mayo/Dr. Tefferi transferred ownership of IND 01731951 to Geron. Geron now owns that MF IND with no hold on it so Geron can move forward with it's brand new, no holds barred IND. Renders the other ET IND moot and irrelevant. Just google transfers of FDA IND and you will find information about this FDA process. Emory University has a nice summary of it.

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The Compromise That All Could Accept for Imetelstat
Tefferi is still at Mayo, but is also is the leader of the MF studies at Geron (new and continuing). Mayo's lifted hold allows both Geron and Mayo to move forward with MF, and other "off-label" and new possibilities. Scarlett can seriously bring aboard a deep-pocked partner, with the proper blood cancer credentials. The FDA can put the Geron hold on the back burner as unimportant, since it has nothing to do with MF. Combination drugs can be contemplated. The FDA saves faced for imposing an ill-conceived liver hold. Geron gets to manage all projects using Imetelstat, and Mayo keeps a hand in all of the research. Cancer patients benefit the most. Geron investors get support from the whole "team", and will benefit. Market manipulators have to reevaluated their short positions.

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yes no new patients in ongoing MF Phase I IST because that trial has not been recruiting patients since January 2014. However, Geron can begin new studies (Phase II) as soon as they 'communicate' with FDA about new IND and development plans for Imetelstat (read: not planning on developing in ET). This is my interpretation of announcement.

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What will happen? I don't know what you mean - "what will happen soon after those 4 months"? I stated that the MF IST Phase I ongoing Mayo Clinic will continue treating the current cohort through end of year and - by deductive reasoning - until Phase II is implemented. There is no reason for Phase II not to be advanced and implemented now. The NCT 01731951 (publicly available) states that the data for the MF IST Phase I cohort will be published in January 2015 so I think all expect MF IST Phase I cohort currently under treatment at Mayo will not longer be treated in Rochester after that date. However, I doubt patients in remission on Imetelstat will be sent home with no further treatment, do you? I doubt Dr. Tefferi is going to drop all of his patients under treatment, do you?

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Whether or not the "old" ET IND (look up the NCT number for me) is ever lifted (or discussed again) does not matter now. Null...void...moot...irrelevant. Let it go gently into that good night. The brand new MF IND NCT 01731951 is not on hold and we begin again with "no holds barred" with respect to moving on up to Phase II. Do not let your imagination fail you now.

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1. Dr. Tefferi will still work at Mayo Clinic not Geron.
2. Geron will sponsor the last 4 months of the ongoing MF IST Phase I Mayo trial.
3. Dr. Tefferi will still be the principle investigator for the ongoing MF IST Phase I Mayo trial.
4. Geron will advance and implement the MF Phase II trial under it's new IND that Mayo/Tefferi gave them.
5. MF Phase II multi center locations will be announced.
6. MF Phase II multi center IRBs will begin review.
7. MF Phase II patients will enroll.
8. Dr. Tefferi will be the chief study officer (chief PI) of all the PIs at the MF Phase II centers.

Not necessarily in this order.

FYI - Sponsorship does not mean spending or only providing the drug. FDA IND sponsors and investigators have specific roles and responsibilities regarding data collection and reporting only. These duties and obligations are published on the FDA website.