The paragraph below is copied from habusa789 and is allegedly off of the currently filed 8K.
If the part I highlighted in bold is substantially correct, and using the phrase "for the substitution", it is Mann saying very clearly that they moved the goalposts after the 2nd submission. (I am not sure I have ever actually heard him say it this directly.) The question is why. It seems a strech to say that it was because of patient health. How did Shkreli convince them that they could not use a device update protocol in this case, which hinges on wheter this a new or an updated device and the critical nature of the device. (This is not a stent or a pacemaker, which could result in a life threatening event, or even an artificial joint which could result in major complications. Furthermore close monitoring of initial patients could have been required.) And was the FDA insider really so much in the dark that he thought access from the drug side of the FDA without access to the device section was sufficient information? I think it is more likely that the device division changed its mind.
In truth the harm has been done and no criminal conviction will undo this crime.
"Mann expected FDA to approve the AFREZZA inhaler that dispenses the novel insulin in January 2011. That, however, didn’t happen. “While we were conducting our trials, we developed a better delivery device. This new inhaler is much more convenient, discreet, and less expensive. It is also more efficient for delivery,” Mann says. “We were able to make it much more convenient and discreet and less expensive. It also actually has a better profile for delivery.” Mann decided to launch with the new device since a later transition might be confusing to patients. “FDA told us what we needed to do for the substitution and we did it all,” he says. “In January, they came back to us and told us they wanted to see two new trials with the new device to bridge the extensive trials that were conducted with the earlier clinical device.” Mann explains that FDA is asking for a 12-week human trial. To recruit the 900 patients for that trial will probably take at least a year, he estimates. Because it will take FDA an expected six months to do their review, the company does not expect the product to be ready for the market until the end of 2012 or early 2013."
BTW recruiting 900 patients changes the calculation of the number of patient screening needed to about 27,000.
As I said before, if you really think about it there have been no positive announcements on financing, partnership, or regulatory action since...the company was formed? The idea and the product itself may be great, but Al has always said these are the least important things in creating a successful product.
