Guidance for the Public and FDA Staff on
Convening Advisory Committee Meetings
Considerations when to Convene a Meeting
In those instances in which FDA is not legally compelled to refer a matter to an advisory
committee, it may nevertheless choose to do so voluntarily. When considering whether
to convene such a meeting, FDA should consider the following three factors:
(a) Is the matter at issue of such significant public interest that it would be highly
beneficial to obtain the advice of an advisory committee as part of the
agency’s regulatory decision-making process?
(b) Is the matter at issue so controversial that it would be highly beneficial to
obtain the advice of an advisory committee as part of the agency’s regulatory
(c) Is there a special type of expertise that an advisory committee could provide
that is needed for the agency to fully consider a matter?
In the event that one or more of these factors is met, the matter at issue should generally
be referred to an advisory committee.
FDA regulates a broad range of products and conduct, which means the preceding factors
must be evaluated in many different contexts. To provide more clarity on when to hold
meetings, the bullets below identify different kinds of scenarios in which one or more of
the factors are often met.
• FDA is evaluating a first-of-a-kind, first-in-class medical product for human use.
• FDA is evaluating a medical product for a significant new indication.
• FDA is evaluating a novel product or use of new technology.
• FDA is evaluating a medical product that involves a significant diagnostic,
therapeutic, or preventative advance.
Essentially, the way I see it, the FDA was required to convene
an "Advisory Committee Meeting". The fact that is will convene only two (2) weeks prior to
the scheduled approval date indicates to me that it may just be a formality.
I received a photo complements of Doyon Insurance in Danbury, CT showing Mannkind's parking lot last monday 2/3/14. The lot is full, so they are pretty busy doing something. I would post the picture if I knew how.
RXR, you were a jerk last year and you're still a jerk. Not a single thing your claimed last year turned out to be true, and now you're back spouting the same garbage claiming it to be true. The issue at hand is due to a ligit vote by stockholders and has absolutely nothing to do with a YONG conspiracy. Get a real job You're showing your ignorance!
I ignored your last year and made 10's of thousands of dollars profit in YONG. I sold at over $6.00 when you were projecting a complete bankrupt company. Go away before you hurt some weak handed investors, like you did last year, that don't have the fortitude to hang on.
This was interesting reading. They had nothing but good things to say about ORIG as compared to their closest competitors. I am hoping to see some positive movement in this thing over the next few weeks. I don't understand why it hasn't moved up yet. They have beat the estimates for the past 5 qtrs. and are proported to start paying a dividend in the next qtr. I expect to see this priced in the low $20's real soon.....
$3 PUT paying just less than 20% for a little over 5 weeks isn't a bad return. That same money invested on the $5 PUT would give you nearly 30% return. For the $5 PUT you would be breakeven at just over $3.50. The $3 PUT breaks even at around $2.50. If you have faith that they get the approval, the $5 PUT is a better return on your investment, if you don't think they are going to get the approval, the $3 PUT gives you more protection.
I'm betting that they get it and have sold both $4 PUTS and $5 PUTS for the May 17 expiration, and covered calls at an $8 strike for the same date. Looking at about $35,000 if I'm right and protected down to about $3.25 if I'm wrong.