Griffin Securties Note - Jan 10 2014

[otherottawaguy]

I am cross posting this just in case we are not reading both proboards forums.

I received a note this afternoon from Griffin Securities with their interpretation of the Adcom Notice received yesterday.

Dr Markey is the author and has been following MNKD for a few years. His other reports on MNKD can be found at:

www.griffinsecurities.com/research-small-cap.php

Here is an attachment of the article:

Griffin Securities Update 10 Jan 2014.pdf (220.83 KB)

And a text except if it does not work:

January 10, 2014
MannKind Corp. Buy
Company Update : Pharmaceuticals
FDA Sets April Fools' Day Meeting
n The FDA has tentatively scheduled an Endocrinology &
Metabolic Drugs Committee meeting for April 1st to review
Mannkind's Afrezza. The PDUFA date is only two weeks after
the meeting on April 15th, and that suggests to us that the intent
is to discuss the drug's label.
n The timing is closer to the PDUFA date than we would have liked
to see, but it still leaves the agency with sufficient time to render
a decision within its statutory deadline.
n This is GOOD NEWS, as we believe the panel meeting is
an indication the agency is prepared to approve Afrezza.
Why else would they have to be advised on the appropriate
patient population for insulin? The FDA has already asked
the Company to conduct a post- marketing study of Afrezza
in children as young as four years old, which clearly means
they have little concern over safety. Indeed, Mannkind submitted
a risk management plan years ago that apparently met
with the agency's satisfaction. Moreover, efficacy has been
demonstrated multiple times in patients requiring basal and
prandial insulin, and the Affinity 2 trial that was designed with
the FDA's guidance showed Afrezza is effective in controlling a
type 2 diabetic's glucose levels when added to a regimen of oral
antiglycemic agents.
n We believe TODAY'S PRICE WEAKNESS HAS CREATED A
BUYING OPPORTUNITY. In the past few weeks, the stock has
been benefited from speculation over approval, and while the
volume achieved yesterday is probably not going to be seen
again at least for some time, we think the general upward trend
will continue.

Enjoy the ride,

OOG

[oracle]

Thanks OOG for sharing! It would be nice if they would post on SA to counter AF and the other negative people in this sector.

[nemzter]

OGG thanks, I was wondering where this came from when I was looking at the YMB earlier.

Go Canada!

[liane]

Thanks OOG!

Someone mentioned this on StockTwits, but I couldn't find the actual note.

[rak5555]

This is exactly in line with where I settled my thoughts after a long grinding day yesterday. The timing tells us,its just about the label and that is extremely positive. Even if the label isn't as open as we want, MNKD (and partner) can get there through phase 4 studies.

Now, if only we could get Matt to say something like this on Wednesday!!!!!!

PS - there was another way I knew this was positive. Some trusted long time longs were starting to pull back on their holdings and we are ALWAYS wrong.

[spiro]

I don't know how trustworthy I am, but I did pull back some shares yesterday for $6.62 and $6.25. But, now I have made a remarkable turnabout from my 24 hour depression. i am now singing " What a difference a Day Makes". I guess my irrational exuberance needed to take a hit, to get me thinking clearly again. The bottom line for me is simple, the world needs Afrezza, parents with kids need Afrezza, the Artificial Pancreas Project needs Afrezza and a lot of us, either need Afrezza now, or will soon need Afrezza. By reducing severe Hypoglycemia, Afrezza will save countless number of lives worldwide. The FDA and others will approve this life changing treatment for diabetes. MNKD should bring a little 5 year old diabetic to the AdCom as their consumer advocate. I guess by now you know how fast my irrational exuberance can reappear.

Spiro

BTW, I do not drink alcoholic beverages or use mood changing substances

[mdcenter61]

Jan 11, 2014 9:34:21 GMT -5 spiro said:

I don't know how trustworthy I am, but I did pull back some shares yesterday for $6.62 and $6.25. But, now I have made a remarkable turnabout from my 24 hour depression. i am now singing " What a difference a Day Makes". I guess my irrational exuberance needed to take a hit, to get me thinking clearly again. The bottom line for me is simple, the world needs Afrezza, parents with kids need Afrezza, the Artificial Pancreas Project needs Afrezza and a lot of us, either need Afrezza now, or will soon need Afrezza. By reducing severe Hypoglycemia, Afrezza will save countless number of lives worldwide. The FDA and others will approve this life changing treatment for diabetes. MNKD should bring a little 5 year old diabetic to the AdCom as their consumer advocate. I guess by now you know how fast my irrational exuberance can reappear.

Spiro

BTW, I do not drink alcoholic beverages or use mood changing substances

Spiro - you da man! This thread, along with my morning coffee, have significantly brightened my day.  Have a great weekend, everybody, and continue to believe!

BTW - I restrict my alcoholic intake only to those days of the week ending in the letter "Y".

[ezrasfund]

Although the last few days have been an emotional roller coaster, I think I have become immune to all of this manipulation. After the morning run-up I put in an order to sell a 1000 shares at $6.88 and went for a few ski runs Thursday afternoon. My position is more than maxed out, so I have to trim it a bit as the price increases. Big picture, I beat the market last year and YTD things are still very good, so there is little reason for gnashing of teeth, even if the stock price somehow settles back to $5 for OpEx as some have predicted.

On the other hand it's good to have some real news to discuss for a change. Ever the optimist (aka "pumper") I have to note that there have been no AdComs for the previous NDA's which were only for Type 1 diabetes. Type 2 diabetes has many more treatment options, and so the question of just how and when Afrezza should be used in T2 is much more complex. This might be the primary reason for the AdCom this time.