FDA goes neutral with new response letters

For years now investors in the biopharma field have often had to spend a considerable amount of time scratching their heads over what the FDA really meant when the agency issued an "approvable" or "not approvable" letter--often over-reacting to the headlines. So now the FDA says that it will issue "complete response" letters for drugs that aren't approved for sale in the hope that more neutral language can calm jittery nerves. These new letters are intended to tell developers what is missing from their application and if possible how they can cure the fault.

Several analysts, though, noted that the FDA's quest for neutrality is likely to lead only to greater confusion about the prospects of an experimental therapy.

"While this new plan may provide more detailed information to the company regarding issues that need to be addressed, investors will likely be kept in the dark on the status of a drug's approvability," noted analyst Jon LeCroy. "Investors will no longer know whether a drug is dead in the eyes of the FDA."

- read the story from eNews

Suggested Articles

Paragon Biosciences has hired Kerensa Jimenez as the new CEO of its capital markets group Paragon Health Capital.

Regeneron has taken a step closer to getting a green light for its experimental high cholesterol drug as the FDA allows a swift review of evicanumab.

An analysis of Gilead’s remdesivir clinical trials found the studies “failed to provide equal representation of Black, Latinx and Native Americas."