Diabetes Mine

[brentie]

Holding Our Breath for Inhaled Insulin Afrezza

"The FDA has granted MannKind a period of three months — until July 15, 2014 – to prepare and submit additional safety and efficacy information necessary for the full FDA review that would determine how soon Afrezza will hit the market. Given the nearly-unanimous advisory recommendations, hopes are high!"

Is this new? It appears in the article that they talked to Matt.


www.diabetesmine.com/

[babaoriley]

This article states: "The FDA has granted MannKind a period of three months — until July 15, 2014 – to prepare and submit additional safety and efficacy information necessary for the full FDA review that would determine how soon Afrezza will hit the market."

"Granted" - an interesting choice of words. But what's with the additional info?

[brentie]

Apr 10, 2014 9:13:15 GMT -5 babaoriley said:

This article states: "The FDA has granted MannKind a period of three months — until July 15, 2014 – to prepare and submit additional safety and efficacy information necessary for the full FDA review that would determine how soon Afrezza will hit the market."

"Granted" - an interesting choice of words. But what's with the additional info?

Yeah, that's a little different than MNKD's press release.

MannKind Updates Status of New Drug Application for AFREZZA(R)

VALENCIA, Calif., April 7, 2014 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq:MNKD) today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for AFREZZA® by three months to July 15, 2014 in order to provide time for a full review of information submitted by MannKind in response to the FDA's requests.

[BD]

brentie, I think the PR is worded rather ambiguously, and one possible interpretation is that the "information submitted by MannKind" hasn't yet been submitted.

[brentie]

True, but if the wording in the article is accurate it would have been refreshing if MannKind had stated it that way and actually shared that information with us. It would have had an effect on the share price.

[BD]

Lots of things "have an effect" on the share price. In this case, I fail to see how there would have been anything actionable one way or the other.

[brentie]

You may be right. It's  probably just me. No one else seems bothered by it.

[babaoriley]

What does seem to affect MNKD rather directly and surprisingly (to me) so, is the biotech index which is getting hammered again today, right along with the NASDAQ. Yesterday's nice rise in the index has been more than wiped out this morning - wow, the volatility is unbelievable!

[4Balance]

Has that article been edited, to remove the mention of the FDA's need for additional info? 

Here's what that quote says now, "The FDA has extended its deadline for three months — until July 15, 2014 – to do a full review and determine whether Afrezza should be approved. Given the nearly-unanimous advisory recommendations, hopes are high!"

A few paragraphs below, Matt focuses on labeling requirements:  "The agency was initially set to decide by April 15, but earlier this week extended the full review deadline by three months. MannKind’s Pfeffer tells us this gives the company more time to court potential partners, but also to work with the FDA on any labeling requirements that might be considered on the heels of the advisory panel’s notes."


Looks like the author had cited some incorrect info that he subsequently fixed, to his credit.

[BD]

Apr 10, 2014 11:30:49 GMT -5 babaoriley said:

What does seem to affect MNKD rather directly and surprisingly (to me) so, is the biotech index which is getting hammered again today, right along with the NASDAQ. Yesterday's nice rise in the index has been more than wiped out this morning - wow, the volatility is unbelievable!

I'm reading Michael Lewis' latest book, Flash Boys, right now and there's a lot in there that explains why the markets are so volatile. Basically, the more the volatility, the easier it is for the HFT algos to front-run trades and profit from price movements.

In a lot of ways it's demoralizing to know that with enough hardware, software and physical proximity to the exchanges, a lot of big banks and hedgies are able to steal money from honest investors. OTOH, the algos are mostly pitting themselves against each other, and if a small-time investor can muster the intestinal fortitude to ride the bucking bronco, there seem to be more opportunities for entry points into solid companies.

IMO, the volatility is being directly fomented by the Big Boys behind the scenes pulling the strings of the media talking heads (and financial bloggers/writers) and I think one of the consequences may be that technical analysis has become less effective--too many artificial "Black Swan"s--and value investing may experience a Renaissance. Of course, I'd prefer if the HFTs were simply outlawed (and the playing field thus made just a bit more level...)

[brentie]

Apr 10, 2014 19:14:32 GMT -5 4Balance said:

Has that article been edited, to remove the mention of the FDA's need for additional info? 

Here's what that quote says now, "The FDA has extended its deadline for three months — until July 15, 2014 – to do a full review and determine whether Afrezza should be approved. Given the nearly-unanimous advisory recommendations, hopes are high!"

A few paragraphs below, Matt focuses on labeling requirements:  "The agency was initially set to decide by April 15, but earlier this week extended the full review deadline by three months. MannKind’s Pfeffer tells us this gives the company more time to court potential partners, but also to work with the FDA on any labeling requirements that might be considered on the heels of the advisory panel’s notes."


Looks like the author had cited some incorrect info that he subsequently fixed, to his credit.

Interesting, thanks for pointing that out. I don't see that paragraph about Matt anymore though.

www.diabetesmine.com/

[nadathing]

"Pfeffer tells us this gives the company more time to court potential partners"

The courting period should have been over by now. For months we have heard "We are pleased with the job Greenhill is doing". We see poster after poster on the YMB say a partnership agreement has been signed, but it is contingent on approval. If signed agreements were in place why would they still be courting partners? Am I reading too much into this?

[ezrasfund]

I am not sure the writer on diabetesmine is being very precise. He probably is not writing for investors who are parsing every word. It is very doubtful that "court potential partners" are Matt's exact words.

[4Balance]

Apr 10, 2014 22:00:57 GMT -5 nadathing said:

"Pfeffer tells us this gives the company more time to court potential partners"

The courting period should have been over by now. For months we have heard "We are pleased with the job Greenhill is doing". We see poster after poster on the YMB say a partnership agreement has been signed, but it is contingent on approval. If signed agreements were in place why would they still be courting partners? Am I reading too much into this?

The YMB is notorious for giving speculators a megaphone. 

Now that we have well-moderated Proboard forums, I rarely visit the YMB.

[jpg]

Apr 10, 2014 20:50:51 GMT -5 BD said:

Apr 10, 2014 11:30:49 GMT -5 babaoriley said:

What does seem to affect MNKD rather directly and surprisingly (to me) so, is the biotech index which is getting hammered again today, right along with the NASDAQ. Yesterday's nice rise in the index has been more than wiped out this morning - wow, the volatility is unbelievable!

I'm reading Michael Lewis' latest book, Flash Boys, right now and there's a lot in there that explains why the markets are so volatile. Basically, the more the volatility, the easier it is for the HFT algos to front-run trades and profit from price movements.

In a lot of ways it's demoralizing to know that with enough hardware, software and physical proximity to the exchanges, a lot of big banks and hedgies are able to steal money from honest investors. OTOH, the algos are mostly pitting themselves against each other, and if a small-time investor can muster the intestinal fortitude to ride the bucking bronco, there seem to be more opportunities for entry points into solid companies.

IMO, the volatility is being directly fomented by the Big Boys behind the scenes pulling the strings of the media talking heads (and financial bloggers/writers) and I think one of the consequences may be that technical analysis has become less effective--too many artificial "Black Swan"s--and value investing may experience a Renaissance. Of course, I'd prefer if the HFTs were simply outlawed (and the playing field thus made just a bit more level...)

I couldn't agree more. In my opinion the more everything is algo driven the more we have an advantage with understanding what has real value and what doesn't.