All of this talk about an appeal reminds me of a letter from GO_MNKD's blog.Here's a portion of the letter:

"The watchdog organization CREW has addressed this issue in a petition to the SEC for an investigation into hedge fund manipulation of biotech stocks. Mr Shkreli • and his involvement with Mannkind are specifically mentioned. I ask that you • and your office, facilitate this investigation, as best you can. Now compare this approach to one of another Company whose stock I own Mela. Mannkind's approach to dealing with the FDA has here-to-fore been akin to that of a pledge getting paddled by a fraternity brother ie 'Thank you. may I have another". Not Mela. This Company treated the FDA in a fashion to which they had not been accustomed: they treated the FDA as they would a bully. They fought back and won Mela is a small company that came up with a machine to help diagnose skin cancer Specifically malignant melanoma , the deadliest kind This has particular interest to me, who is of Irish decent , and in retirement . has begun lying on the Sea Island beaches all day. The machine would be waved over the suspicious lesion , do all sorts of funny calculations, compare the result to a huge data base developed by the company, then come up with a diagnosis. As someone who took his share of dermatology in medical school, this seemed a godsend. The standard of care , up to this point, has been simply eyeballing it, then guessing. Granted some guesses were better that others, but it was still guessing- with a biopsy as a chaser. No doubt the thing was desperately needed, and the early data looked great--particularly cutting down the need for a biopsy. Mela's management enters into a binding protocol agreement with the FDA This is an unusual set up, but virtually guarantees approval if the mutually agreed upon study criteria are met. Great. Everybody signs off, everything looks good.

Trouble was, all this was all done with the OLD FDA • the one under the Bush regime " We don't need no old stinking binding agreement---was the new motto, under the NEW FDA management (A slight exaggeration. but you get the point). There is such a thing as an advisory panel that the FDA uses at its discretion. It is filled with outside experts that review the data, and advise the FDA whether they think something should be approved or not Many times they do not feel the need for a panel The message here is that we will use experts only if we think we need them, and most of the time we don't think we need them. A tad arrogant but that's probably just me. Even if the panel says yes, the FDA can, and often does, say no. A company can request a panel, but is loathe to because in so doing it suggests that the FDA may not entirely know what it is doing. And as we shall see, our beloved agency can be a wee bit vindictive. Nevertheless , Mela requests a panel. To this , the FDA says essentially 'we don't need no stinking panel" and proceeds to reject the device. Stock of course tanks They request further studies, requiring years, millions of dollars, all of which would probably bankrupt the Company. Here Mela does four things to punch back at the bully, and eventually win.

First they insist on a panel after being rejected this is almost never done. The FDA doesn't like this one bit, and in a bitter pre-panel prejudicial summary. lets Mela have it with both barrels. So much for an even handed agency that only has the best interests...blah, blah blah. You know the drill. Nevertheless, in a narrow vote Mela wins. I listened to the panel discussion, and I think all the clinicians voted to approve, not seeing eye to eye with the FDA statisticians who were pretty much convinced that "eyeballing it" was as good as you could get. Mela played another card: a political one. It inserted itself into a Congressional investigation by the Energy and Commerce Committee on the subject of the FDAs stifling new device development. The FDA admitted in sworn testimony that , well it should not have rejected Mela before it convened and listened to a panel. Yea, shouldn't have., in fact it went against its own regulations . Surprise, the FDA looks, well, vindictive.

A definitive decision should be made by the FDA within 90 days after a panel has voted. These are again, its own regulations. But since we've already been down this road . and that silly Congressional Committee has disbanded, why lust not only look vindictive but BE vindictive. The FDA lets the deadline go bye without saying a word. Six months go bye, and Meta has had it. Essentially sues the FDA via a Citizen Petition for a decision. At the same time they apply to the European version of the FDA, and get a relatively quick approval. Finally, late last year, the FDA approves the device. and the Company is set to send out its potentially life saving technology to dermatologists shortly.

My point in all this is that something has to change. More biotechs will take the aggressive, self defensive approach exhibited by Mela, and less will sit passive. It is hard to blame them. I would like to invest in young biotech companies again. I know something about their products. and can do quite well if given (in the words of our President) a fair chance. The current process and the FDA make this impossible. Little people like myself will not commit funds . Even large investors will give it up. They, least of all, will not be played for suckers. Development companies will move off shore, welcomed by a venue where they can get a fair shake, and submit their products for review to a foreign agency that will render a quick, informed decision. "

http://afresa.blogspot.com/