FDA's way of saying that (1) you can expect further delay after filing "and it isn't our fault", and (2) watch closely.....very,very,very,very,very closely WHO is on the committee. Committees are where bills (and NDAs) go to die.
Report him. He is constantly doing this. I have flagged his post and reported him to Yahoo. Who needs Punks like this?
Aren't you the same Sap who assured everyone that he would be gone by October 15th??
Don't you ever tire of making a public #$%$ of yourself?
Leave the predictions to someone who has an inkling of what they speak.
You stick with name-calling. It suits you better.
Don't bet on it. This fraudulent FDA, at the urging of self-serving charitys and big pharma, are prepared to place as many roadblocks on SRPT in the future as it has in the past. This is how it works under an Obama administration.
Today's Release from FDA ended as follows::
""The FDA also stated that “[a]dditional discussion between the sponsor and the FDA will be necessary to determine what would constitute a complete NDA.” "
In short, AFTER SRPT crosses their Ts and dots their i's, FDA will change the Goalpost....once again. FDA is Fraud.
Who should be watching you?? Maybe we should. Maybe someone will. Maybe a relation of the boys you seek to deprive of medication will watch you. Look behind you. They could be following you.
Hear that Mother and Father?? The so-called Charaities are out to make the SRPT CEO fail, and therefore SRPT fail!
The Charities have no regard whatsoever for which drugs will help the boys. No, now its ALL about how much money the Charities can make "picking the winner"! If the Charities can't win, then they'll make SURE that the Drugs will also fail.
Shame, Shame, Shame!
If FDA wishes to act like this towards SRPT, then I strongly encourage you, ALL the parents, and ALL the MD organizations to write to the FDA, their Congressman, and their Senators, to have the FDA CLOSELY....VERY CLOSELY review the APP from RNA to ensure that a Drug that has such Side Effects NOT be approved to the detriment of the boys.
My Congress man has already responded to me, saying he will look into this and will PERSONALLY reply to me. I have also contacted the MD Charity I give to, and told them of my concerns, and they, too, have ASSURED me that they are in the process of reviewing their giving to RNA. They, too, have ASSURED me that they will respond to me with their final review.
ACT NOW, people!!
if they had financial incentive?? Is that their criteria now?? Did they drop their criteria that they should contribute to cures for Duchenne?? Isn't that a consideration anymore?/ Do these "charities" now only give to those who ensure that the "charities" receive a "financial incentive"?? How utterly disgusting these "charities" have become!!
Precisely. It's not a charity, its a mutual fund and should be investigated by the various state security agencies! I would strongly encourage everyone here to contact their state government security agencies to determine why such "chairties" are not filing the appropriate documents with their agency.
The last thing any responsible individual should be doing is supporting such "bait and switch' tactics. If one thinks by sending them money, that it is being used for charitable purposes, they are sorely mistaken.
Rumor is floating..........
Grab the popcorn and Sit back and enjoy. Should last a long, long, long time!!
Seems to me that there's a difference between the ability to develop an effective drug to treat a specific disease, in a matter of days; and actually produce that drug in massive quantities.
You have quite the imagination, son. Watching too much cartoons I believe. Now get your homework done or I'll take away your ipod.