FDA places Geron's Imetelstat on partial hold for myelofibrosis

The FDA has imposed a partial clinical hold on Geron's (GERN) Imetelstat treatment in a trial for myelofibrosis, as the drug may be toxic to the liver.

Geron can't enroll new patients into the study, although patients who are benefiting from the treatment will be able to continue receiving it.

The FDA's action adds to the full holds it placed on Phase II trials for essential thrombocythemia and multiple myeloma.

Geron's shares are flat after being higher earlier. (PR)

Comments (2)
  • starcorral
    , contributor
    Comments (1743) | Send Message
    Until there is a story which states categorically that the FDA has in fact completed it's obligation to send formal notification of the "hold", I will regard the "hold" as one more action whose primary purpose is clear. You don't have to watch "House of Cards" or be a conspiracy theorist in order to have reasonable concerns that impropriety is part of decision making. Any person reading my rant who doubts the AMA, the FDA, and private interests have spent time speaking in whispers is probably still mourning Timmy and Lassie leaving our curved B&W TV screens.


    Impropriety is an endemic reality. Example: "We will continue to buy T-notes, but there is a change on the horizon" Meaning: "grab you butt interest rates will be rising soon". Opposite signal example: "We will continue to buy T-notes and gradually pull back as the economy warrants".


    "Facts" themselves are simply descriptions of demontstrable truths; it is how they are delivered and perceived that sparks reaction. So while riding by on a horse delivering a message that the "British are Comming" could provoke a full range of reactions, the one I believe was conveyed was "Get ready to flee or fight - make your decision now and prepare - God be with you."


    The power of suggestion moves the market, just as it moved Vince Foster to take his own life; we simply cannot deny manipulation. Consider Obama and Kerry bluffing Putin and Putin coming back with a virtual "KMA". In the case of stocks doing a teeter totter, always bet on manipulation. This is not paranoia, this is Business 101. I believe Robert McNamara would smile and agree.
    20 Mar 2014, 11:41 AM Reply Like
  • valuemeister
    , contributor
    Comments (14) | Send Message
    I have to agree with Starcorral, I have lost over 1 Million dollars from sudden out of the blue FDA decisions in late stage clinical trials of transdermal non-toxic drug delivery because someone found some piece of data that was overlooked many years before in earlier MOUSE trials what was effectively meanlingless because it has passed human safety trials. Meanwhile we see horrific drug after horrific drug hit the market and massive lawsuits follow. It's inherently corrupt to the core! Stuff like Acetaminophen should never have been made over the counter. It's the #1 liver toxic drug putting tens of thousands in the ER every year and killing many kids and adults. After decades of this slaughter the FDA finally comes out with some new guidelines and warnings. It's as corrupt as it gets. Originally I invested in GERN because of the plethora of Patents, nearly 1,000 patents under their belt. The intellectual capital was staggering. But just the WARF patent alone seemed like the diamond mine of a lifetime. Then again due to corruption, the WARF patent gets yanked without regard to investors who invested because of that value!! Effectively, it was a theft of hundreds of billions of dollars who MADE AND ADVANCED the science even when it was politically unpopular. Now the vendetta against GERN continues, even though it is divested from the Stem cell business that should have made it a Trillion dollar company. As a shareholder I've warned GERN executives many times about the massive power structures that have them in their crosshairs for tinkering with Stem cells. Apparently they just won't let it go and are out to destroy GERN at all costs. Yet GERN's Imetelstat which has nothing to do with stem cells and is based on Telomerase technology also holds incredible promise as a CURE for many types of cancer. And so then there are those SALIVATING at STEALING GERN's Telomerase technology for pennies on the dollar (like they did with the WARF patent) from investors if they can get the FDA to shut down the company. As such I've gone from GERN investor to GERN trader, as these crooked manipulations are so very blatant. It's as if they thumb their nose even at the investment community and say, hahaha... what are YOU going to do about it?
    21 Mar 2014, 09:46 AM Reply Like
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