I have listened and watched it all..never seen such a delay tactic like this before and that is what it is exactly .produced by the FDA itself.
Now i am wondering how much monies prosensa paid out to certain people..Anyone with a science background at all can see that prosensa's drug should be halted.or taken off for the treatment of dmd.Talk about fraud. huh
Prosensa's drug for dmd is far from a good treatment with the toxic effects with low doses that cannot produce unless you up the dose amount and then it would be severely toxic.Long term dosing with this drug would be insane.
a small part of that story-
What’s hard to understand,” says Mindy’s friend Jennifer McNary, “is why the whole Duchenne community and the FDA aren’t pulling together behind eteplirsen.” McNary, who lives south of Boston, has two sons with the disease. Maternal genetic predisposition sometimes results in such sibling pairs. Max McNary, 12, gets eteplirsen in the small Sarepta trial; over the past two-and-a-half years, his symptoms have eased remarkably. Max’s older brother, Austin, 15, didn’t qualify for the study because he was already in a wheelchair when it started. He’s declining physically, losing the use of his arms and having trouble feeding himself.
“Why doesn’t the government let me have eteplirsen?” Austin asks when we meet. He waits for an answer, which I don’t have. His mother joins the conversation: “The FDA’s inaction,” she says, “is killing my son.”
Truth....... i have suggested a new pettion to have the fda reworked and fire the top 10 and have a big investigation.will she start one?
I do have a crossbow ,,native american'' cherokee'' but also a tad of powhatan direct deccendant of pocahontas as well no kidding.
plain flat out..............the fda is slapping that pettion and the parents in the face.
this does not mean it is in stone....'' The FDA can come back with a meeting and change it completly again for a much shorter time.
Watch ..it is all about the monies........they will over ride the recent fda minutes
a very deep pocket biotech to bring all these many drugs to market.''a biotech that can pay off the fda good and have billions''
Before earnings,based on big demand for gild's drugs and pipeline.
Someone needs to take notice,what the fda just did was wrong..these kids are slowly coming into death man.the changed their minds ''again''