The FDA specifically requested:
1) "CURRENTLY AVAILABLE DATA" regarding "clinical utility in the MARKETPLACE" and updated safety information
2) Reformatted data related to the bioequivalency of Medtone inhalers
3) Package label clarification and resolution
That's IT!!!! Not a problem. All were available as of the date of the request.
Yes Sir. The science has always been on our side, solid science,the kind of science upon which the FDA bases its decision. We also have marketing on our side, meaning Dreamboat which in the end from a marketing perspective will be just as big as the iPhone. We also have solid management on our side, the kind of multifaceted management capable of putting together 41 outstanding studies with 5000+ patients, capable of building an award winning world class manufacturing facility, and facing down a CRL with unshakable unmistakable "CURRENTLY AVAILABLE DATA."
have you seen the FDA letter? i have not. while i do not disagree with your characterization of what we have been told, i would argue we have been told NOTHING by FDA, only by the same company that has told us a few other things (partnership, only 2-4 week delay, etc.)
sorry, credibility of management is low.
Management will not disseminate blatantly false information or misinformation regarding something as concrete as a CRL -- too easy for lawyers to dig that up. And I disagree with your characterization of management. Management has been overly gungho, for sure; has withheld some information that it didn't wish to comment on; but has not blatantly lied to shareholders.
I'm thinking as soon as FDA and MNKD have the sit down, it'll be all out and we'll see that partnership. I'm just guessing, but it seems logical. That's why I'm holding what I have and not going any where. I'm just a small fry with about 5k shares so it’s not like I can move the price.
Other stocks I'm in right now:
PGN (progress energy) I like their dividend and I like the company. I've worked with them in the past and they have really strong management, and they've been updating their plants the last couple of years.
SHAW (The Shaw Group Inc.) I have some friends that work for them (I tried to get a job with them out of college, but decided to go somewhere else (I'm kicking myself now)), and SHAW is working on a nuclear plant design which is being built as we speak. Once this goes up it's going to a game changer for the power industry for right now SHAW is looking at a monopoly in the nuclear power design for the US. AREVA tried getting theirs approved, but got rejected, so they're back in Europe tweaking some things. There's no dividend, but talk about strong leadership and strong employees.
HGT (Hugoton Royalty Trust) is one that I like the dividends. Natural gas is going down b/c the summer time is approaching, so this would be a good one to get into during the summer. Come fall and winter I think this will really start to build up again, and right now it’s looking like 7-8% return on the dividends. For a safe play this one seems like a no brainer.
That's about all I'm looking at right now besides MNKD. I recommend you do your own research, but personally I think these are good companies to look into. You make your own decisions.
HGT is an interesting proposition, however EPS of 1.01 does not justify dividends of 1.36.
Maybe consider AGNC, CIM, or NLY if you like big dividends, nice stocks though. I really like PGN thank you, MNKD is an interesting pick, maybe play both them and GNBT to see about Oral insulin. Of course do your own research before investing, and I am not an investment advisor.
Disclosure: Long GNBT
The shorts are betting big on FDA requiring an advisory panel because that could add another 8 months to the approval process and send the stock to $3 -- for sure. But it's not going to happen. So when the end of review meeting passes without an "agreed" advisory panel," you're going to see some short covering.
"If the FDA was so specific in its request then don't you wonder what the items are in the CRL that management won't release because they may be interpreted as being "negatives" by the analysts and shorts?"
"I guess the term "specific" varies with the situation relative to each individual's point of view."
Just a thought!!!