FDA Places Geron’s GRNOPC1 IND on Clinical Hold
MENLO PARK, Calif., May 14, 2008 – Geron Corporation (Nasdaq: GERN) announced today that the company received verbal notice today from the FDA that the company's Investigational New Drug (IND) submission for GRNOPC1, a cell therapy for spinal cord injury, has been placed on clinical hold. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing investigation.
"We have not yet received a letter from the FDA explaining the decision to place the submission on hold, so we are unable to comment specifically," said Thomas Okarma, Ph.D., M.D., Geron’s president and chief executive officer. "Once we have the letter and have had a discussion with the agency, we will communicate our findings and our thinking to shareholders. We are disappointed with this action given the interactions we had with the FDA over four years leading to the filing, and the breadth and depth of the submission, some 21,000 pages, predicated on those discussions with the agency."
FDA has the budget for a few thousand more professional employees to fill the gaps in inadequacies in safety and new technologies.
So they are leaning on the side of safety. Anyone here that has the guts to be condemned no matter what decision you make, step up and take a job with FDA. I might do the same, because I am a little crazy to take a job like that. Would you?
Posting old news is fun!
November 3, 1908
William Howard Taft beat William Jennings Bryan in the race for president!
Here we have geronrocks illustrating the filtering of perception that comes from is close to 8,000 shares of Geron. Yes, the FDA hold is old news, 5/14/08, but so is Okarma's, "Once we have the letter and have had a discussion with the agency, we will communicate our findings and our thinking to shareholders."
Does it take over a month to get a letter and discuss this with the FDA? Okarma has the letter and is not disclosing the contents until he can put the proper positive spin on its contents. His lackadaisical treatment on shareholders is old new too.
Your Buddy from the Department of FDA Hold News Is Know To Okarma
More breaking news.
In 1611 Galileo came to the attention of the Inquisition for the first time for his Copernican views. Four years later a Dominican friar, Niccolo Lorini, who had earlier criticized Galileo's view in private conversations, files a written complaint with the Inquisition against Galileo's Copernican views. Galileo subsequently writes a long letter defending his views to Monsignor Piero Dini, a well connected official in the Vatican, he then writes his Letter to the Grand Duchess Christina arguing for freedom of inquiry and travels to Rome to defend his ideas
In 1616 a committee of consultants declares to the Inquisition that the propositions that the Sun is the center of the universe and that the Earth has an annual motion are absurd in philosophy, at least erroneous in theology, and formally a heresy. On orders of the Pope Paul V, Cardinal Bellarmine calls Galileo to his residence and administers a warning not to hold or defend the Copernican theory; Galileo is also forbidden to discuss the theory orally or in writing. Yet he is reassured by Pope Paul V and by Cardinal Bellarmine that he has not been on trial nor being condemned by the Inquisition.
History repeats it's self.
I tend to agree with you that they have the letter. but posting an old news release is just stupid. your post should have simply been....Does it take over a month to get a letter and discuss this with the FDA? Okarma has the letter and is not disclosing the contents until he can put the proper positive spin on its contents. His lackadaisical treatment on shareholders is old new too.
President Bush Outlines Iraqi Threat.
Iraq's weapons of mass destruction are controlled by a murderous tyrant.
you're right. it is fun.