Transcript:
Steve McDonald: Our guest this week is Marc Lichtenfeld, the biotech and pharma strategist for The Oxford Club. He’s here to talk about something that I think sounds like something that hides under your bed when you’re a child: a PDUFA.
Marc Lichtenfeld: Well, it does sound like a monster for some of the biotech executives.
SM: If you don’t eat your vegetables, the PDUFA will get you.
ML: Yeah, and you can see why it would be so scary for some pharma and biotech CEOs.
SM: Well the whole industry is scary as far as I’m concerned…
ML: Well, PDUFA stands for the Prescription Drug User Fee Act. And this is a law that was instituted in the early ‘90s that basically makes it so that the drug companies – the pharma and biotech companies – pay the FDA for it to review their drugs and decide on approval or rejection.
And this is important because there’s something called the PDUFA date. So when a company applies to get a drug approved, it is given a PDUFA date by the FDA, which is the date that it’ll either get the “yes” or “no” – approval or rejection of its drug.
So you’ll often see a company release that its PDUFA date is November 3, and you know that by that date, the FDA is going to rule. So if you’re the CEO of a biotech or pharma company, you’re sitting there at your computer waiting for that email to come in from the FDA saying “yes” or “no.”
SM: Now, is this after all the clinical trials?
ML: Right, yeah. So the company conducts all the clinical trials. Then it submits its application to the FDA with all the supporting data, and the FDA gives it the PDUFA date, at which point it will get that decision.
And it could come early.
SM: See, I thought the FDA monitored the clinical trials as they were going on.
ML: It does, and if something is going wrong, it’ll put a stop to it. Sometimes if things are going exceedingly well, it’ll actually –
SM: Fast-track it.
ML: Fast-track it. Or it could even stop a trial early to accelerate the application for approval.
But for most drugs that make it all the way through Phase 3 trials, the company will submit the application to the FDA – and sometimes it’ll do it even if the results weren’t great. It’ll just throw it at the wall and see if anything sticks, and the FDA will then make that ruling on or before the PDUFA date.
SM: Now, is the PDUFA date published? Can our Members see it somewhere so that they can say, “Well, on this date we’ll have a decision. I might buy it that day.”
ML: Yeah, the companies will usually release that date as well. On the FDA’s website you can find it. You’ll probably have to do a little bit of searching for it. But it is public information. Once the company has that date, it’ll usually release it and let everybody know …read more
Source:: Investment You
The post Getting the Market Right: Marc Lichtenfeld Explains PDUFA Dates appeared first on Junior Mining Analyst.