It seems immediately clear why an endoxic understanding of probabilis led to the modern translations "reputable", "plausible", "believable", "approvable", or "approved".
And some drugs that won approval in Europe have only received "approvable" letters from the FDA, meaning they will not be allowed on the market without more information.
And some drugs that won approval in Europe have merely received "approvable" letters from the F.D.A., meaning they will not be allowed on the market without more information.
Because the F.D.A. letters are not released to the public, investors may be less informed than they are now when companies announce that they have received an approvable or not approvable letter, said Jon LeCroy, a pharmaceutical analyst at Natixis Bleichroeder in New York.
Regulators issue an "approvable" letter for Clarinex in February 2001, but refuse to actually approve the drug until Schering proves that it can be made safely.
He blamed the stuffiness of the country's old-fashioned democrats for the Nazi victory, calling the results at the time "a perhaps unwise but fundamentally sound and approvable revolt of youth against the slowness and irresolution of 'high politics.' " In his memoir, Zweig did not excuse himself or his intellectual peers for failing early on to reckon with Hitler's significance.
In February 2005, the F.D.A. issued an "approvable" letter, which Discovery said meant that the drug would be approved as soon as it ironed out some manufacturing issues.
Approvable letters detail the steps a company must take to win final approval from the F.D.A.
And it does so to such a great degree that drug stocks tend to run up ahead of the so-called PDUFA date, a deadline by which the FDA must issue a public statement about whether a drug is approvable and what else a company needs to do to get it approved.
Now, however, Amylin has received an approvable letter for Symlin from the U.S. Food and Drug Administration and Symlin could receive final approval in the second half of 2003, pending the results of a currently ongoing clinical trial, according to Cook.
