Monday, March 14, 2016

Smallish Follow-Up: On FDA Priority Review Vouchers -- And Public Policy

On just this past Friday, we mentioned the virtual sweepstakes underway in Delaware bankruptcy court, for various risk-taking hedge funds -- to eventually profit handsomely, from the Chagas-related PRV FDA might ultimately issue -- to KaloBios about a year or so, from now.

We won't rehash our (decidedly skeptical) views on that one, from a public policy point of view -- just search "Shkreli" in the box above. That will offer the readership the gist of it.

To be clear, I would sharply contrast that KaloBios potential PRV -- with Merck's soon to be pending one [late 2014 backgrounder, on that discussion, here -- with a hat tip, and credit to, our good friend "Birdman"].

Yes, Merck is highly likely to eventually win a PRV for its work in bringing the Ebola vaccine to market -- though Merck won't be making an FDA filing until early 2017. That voucher seems to make substantially good public policy sense -- for without it, who knows how long the 2014-2015 Ebola epidemic would have lasted, in Africa. The vaccine seems 100 per cent effective, and has already been a game changer, there.

That said, we will continue to hope that the innocent investors and creditors of KaloBios [and of Mr. Shkreli's one or two man (alleged) crime sprees, at all the other companies] will one day see some recovery. . . But we still view the Chagas PRV as an old drug (decages ago deemed safe and effective, in Latin America -- but never FDA cleared), being used largely to game the regulatory incentives system, here.

Onward, as ever, with a wide Monday Irish smile, and twinkling, but now crinkling, emerald eyes. . .

No comments: