The Mannkind Saga

The Martin Shreli letter

From this article:

“It was January 2011 when the FDA was scheduled to make its first yea-or-nay ruling on Afrezza. The first Phase 3 trials looked as encouraging then as this year’s Phase 3 numbers do now. In fact, it was widely presumed that Afrezza was a slam-dunk as far as the FDA’s approval was concerned. As evidence of that idea, an FDA employee named Cheng Yi Liang — who was later alleged by the SEC to have traded stocks in advance of 19 different drug approvals — had already taken his position in MannKind before the final FDA decision was due. How would he know how, or even if, to trade had he not had access to some sort of privileged information that an approval was on the way?

Incredibly enough, that wasn’t even the most questionable decision made regarding Afrezza’s first rodeo with the Food & Drug Administration.

The original announcement date was supposed to be Dec. 29, 2010. But on Dec. 25 of that year, hedge fund manager Martin Shkreli sent an email to at least 12 FDA employees explaining that the administration not only shouldn’t approve Afrezza, but had an obligation not to approve the drug.

If you think that’s unusual, you’re right; the FDA shouldn’t even be allowed to receive third-party opinions about pending drug approvals. While it’s not clear if Shkreli’s input in any way influenced the final ruling, clearly he thought his comments would be influential enough to bother sending. Indeed, the way things transpired after his e-mail are certainly suspicious.

On Dec. 28 — the day before the original 2010 PDUFA date — the FDA informed MannKind it needed to delay the decision. On the new announcement date of Jan. 18, 2011, the Food & Drug Administration denied the new drug application, citing “bioequivalency” concerns.

The end result was another two-and-a-half years’ worth of pretty much the same research MannKind had already done.”

More information about Martin Shkreli’s actions:

The panic before the Adcom Meeting

Coming soon

The “erroneous” news article stating that the FDA had denied Afrezza causing a major selloff in a few seconds

Coming soon

TASE semi-failure

Coming soon

Sanofi dropping of Afrezza

Coming soon

The new CEO that never became CEO

Coming soon

Castagna is the man!

Coming soon

Stay tuned for…more dilution

Coming soon

The Mannkind saga never ends.

You may also like...