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Reply With Quoteseriously..!! we have been waiting long for thisOriginally Posted by fortune419
I heard they had 90 days, back from when they said there would be a two week delay. I dont have any links or articles to prove this though, just talk i read somewhere.
seriously..!! we have been waiting long for this
Ampligen will be approved 100%
yeah the question is just when it will be approved.
I think it WILL be approved. It's just now a matter of when.
probably sometime this year. Thats about all I can bet.
My life sucks, I need money and HEB is not approved yet... FDA, where are you?
Think I heard that somewhere too. If that is true maybe we will hear something late august.
Answer from the Pr women
Ok guys i'v got a answer from Dianne
A Wall Street Analyst refers to the FDA missing PDUFA dates as the “PDUFA Netherworld”. This same analyst also refers to the FDA as “Forever Delayed before Approval”.
This situation is not that unusual.
The following is another example of a company that experienced the PDUFA Netherworld….
Examples of PDUFA Netherworlds:
Previous Page
The FDA Can't See the Forest or the Trees
The FDA Can't See the Forest or the Trees (CYPB, FRX)
Brian Orelli
December 9, 2008
It's been over a month since Forest Laboratories (NYSE: FRX) and Cypress Bioscience (Nasdaq: CYPB) said that the Food and Drug Administration was indefinitely delaying its decision about whether to approve their fibromyalgia treatment, milnacipran.
The companies certainly wish the FDA would do something, but they're not sitting on their hands, waiting demurely. In true in-your-face fashion, Forest and Cypress released data from a third phase 3 trial, which confirmed the results of the two trials that the FDA is currently reviewing. Of course the companies were nice about it -- no need to **** off the FDA reviewers -- but I can only imagine that the executives were smiling as they issued the press release.
The companies didn't offer much data from the trial -- they're likely saving it for a scientific meeting. Hopefully the FDA won't need it, either; a request for the data could further delay the approval process, which is already nearly two months beyond the PDUFA date.
Forest and Cypress must be annoyed, but they've got company -- Eli Lilly's (NYSE: LLY) prasugrel is currently suffering a delay and CV Therapeutics' (Nasdaq: CVTX) Ranexa recently had to endure a wait. The indefinite delay -- as opposed to the more standard three-month kind -- makes launching milnacipran difficult, to say the least. The drug will enter the market against established players like Eli Lilly's Cymbalta and Pfizer's (NYSE: PFE) Lyrica. How can the companies hit the ground running if they don't know when an approval might be handed down?
I think we're likely to see an eventual approval. Hopefully this latest release of data reminds the FDA that it's got an application gathering dust. I'll join in the company's call: Approve the thing already.
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A month after on Jan 15 Savella or milnacipran was approved. That's about two months after the FDA told FRX they needed more time (and did not give a timeframe for when their decision would be made). Now here we are a little over two months after the FDA told HEB two weeks. It appears then, that maybe the FDA only cares about big biopharmas.
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