Chang Yi Liang was a chemist working in the FDA. His senior position gave him access to the FDA's intranet internal email communications network. By accessing the network he was able to review internal communications amongst senior FDA officials in charge of new drug approvals.
Chang Liang's access to the FDA network enabled him to successful trade and profit successfully on 27 insider trades. Prior to our last CRL Liang realized Afrezza was about to be approved. He purchased 18,000 shares of MannKind at $8.41 per share. It is important to note that Liang never list money on his insider trades.
What happened? Why did we receive a CRL? At the last moment a hedge fund manager, Martin Shkreli, wrote a letter to senior FDA officials pointing out that Afrezza's approval would violate the FDA charge to protect public safety since the inhaler device, Dreamboat, had not thoroughly tested. The FDA agreed and a CRL was issued. You can confirm all this by googling "Chang Liang FDA".
Now, since Dreamboat has been thoroughly tested and vetted in new Phase III trials and achieved stellar results, what does that tell you about Afrezza's chances of approval? Something close to 100 percent, I believe. Jmho.
Sentiment: Strong Buy
I think what's most interesting is that Skreli announced, in his letter, that he would personally profit from the delay in approval, and yet the FDA went ahead and ordered the delay. He was very up front that he had a short interest, and the FDA handed him money on a silver platter. Probably LOTS of money. And now he has his own BioTech company.....what could possibly go wrong there? Whenever they finally have a drug up for approval, all of the people burned by Shkreli should get together and compose the mother of all letters to the FDA, while going heavy short.