Think you're referring to the Mannkind briefing doc, not the FDA Briefing Doc.
From page 31 of the FDA Briefing doc.
In conclusion, the available data from clinical pharmacology studies for AFREZZ does not conclusively support use in patients with underlying lung diseases. The data from clinical studies will be considered along with the available limited PK results to develop the final labeling recommendations. (emphasis added)
And from page 32 of the FDA Briefing doc:
Reviewer’s comment: In Afrezza program, studies evaluating the impact of hepatic and renal impairment only assessed the impact on FDKP exposures. Literature information for impact of organ function impairment on insulin exposures is also limited. Therefore, we are considering a labeling recommendation suggesting that the dose requirements for Afrezza may be reduced in patients with renal or hepatic impairment. Careful monitoring and dose adjustment be considered as necessary. (emphasis added)
Mannkind (MNKD) Briefing Docs Quite Negative, But No Death Blow, Summer Street Says
10:30 AM ET, 03/28/2014 - Street Insider
Summer Street analyst Bart Classen commented on the FDA briefing documents for Mannkind's (NASDAQ: MNKD) Afrezza, calling them 'quite negative' but not a 'death blow'.
Classen comments, "The FDA's briefing documents were released today ahead of the April 1stFDA advisory committee meeting of MNKD s inhaled insulin, Afrezza. Based on Questions 1 and 2 to the advisory panel, the FDA appears to concede that Afrezza is less effective than injectable insulin in both type 1 and type 2 diabetes and the body of the briefing documents indicate that Afrezza is associated with more ketoacidosis (a life threatening condition of insufficient insulin). The FDA also appears to concede that the data used to instruct a patient to convert an injectable insulin dose to inhaled insulin dose is deficient. The pulmonary branch has strong reservations on whether large pre-approval safety studies should be performed for the Dreamboat inhaler because it is more effective than the Medtone-C inhaler. The panel is stacked with professors at large academic centers and we expect they will share our view that Afrezza should not be approved."
Worth noting from TUdiabetes site.
Former exubera patients have spent many years on inhaled Afrezza without issue and the FDA has approved many, many new inhaled drugs. The JDRF tested Afrezza and a video can be seen:
May be problematic. That sounds pretty vague. Note a numbe of Diabetes organizations are slated to testify at the ADCOM.
"The total approval rate jumped nearly 20% to 74.6% after companies submitted responses to the US Food and Drug Administration’s (FDA) CRLs. A third round of responses brought that percentage up an additional 8.3% to 82.9%."
From the Regulatory Focus page of the Regulatory Affairs Professionals Society. 9sure would be nice if Yahoo allowed the posting of relevant urls.).
Well all the sound and fury signifying . . .
will start to subside on Friday if the FDA releases background material for the April 1 hearing.
Think pretty clearly today's action was related to the Summer Capital call, which is reportedly negative, but so far very hard to find specific info. on it.
Of course the other possibility is that the docs given the FDA have leaked and there is something negative in them. However, if that is the case there has been no hint of it. Even the scanty info. available on the Summer Capital call does not make mention of any new material
Tomorrow should be interesting. More detail on the Summer Capital call will come out. That may drive the price for awhile depending on what they have to say. Friday, should give a much clearer picture of where Mannkind is going if the FDA releases background material.
But time will tell, it always does.
To announce a deal now would show disrespect for the FDA, like what they were going to do didn't matter or was a foregone conclusion. You don't want to do that with an entity that has such power over you.
I have no idea. Just saying the option market seems to think something significant will be decided. Open interest drops dramatically for the options that come after and for the options before.
With 377 million shares outstanding, price per share of a $11 billion buyout is still well over $20 a share. Even if you figure in possible dilution with exercise of options, conversion of debt raising share to 500 million, still pps is over $20. I'll take that.
The options market seems to think this is going to be decided by May 17th. The open options interest for the calls and puts expiring on May 17th is the biggest for any expiration date. It is interesting that there are big open interests for BOTH the puts AND the calls..
The open interests for all puts and calls with an earlier or a later expiration date are dramatically lower.
To illustrate, the open interest for the 6 call is 12,844. The open interest for 4 put is 23,720. No other put or call for any other expiration date comes close to approaching these numbers.
Here's what they said as to why:
Why did you decide to change your ERP / accounting solution?
As a publicly traded pharmaceuticals and manufacturing company, MannKind Corporation needed a system that would not only handle our daily operations from financials, inventory control, manufacturing, and production - the solution also needed to satisfy SOX and GxP compliance requirements as well as meeting the stringent FDA requirements we are subject to.
Doubt they would do it before FDA action. Shows disrespect for FDA suggesting that its review was a foreground conclusion. Not a smart thing to do.
If high/low OBV is increasing that suggests that the price will go up. It also suggests that stock accumulation is going on.
High Low OBV is calculated by doing a running total of volume adding the volume if the day's price is higher than the previous day's high and subtracting it if the day's low is lower than the previous day's. You can do a rough calculation here by noticing that each time MNKD's volume exceeded 10.000,000 the day's high exceeded the previous day's high.
Date Open High Low Close Volume Adj Close*
Mar 19, 2014 5.66 6.20 5.63 5.69 19,204,300 5.69
Mar 18, 2014 5.59 5.67 5.58 5.65 5,922,800 5.65
Mar 17, 2014 5.65 5.69 5.53 5.58 5,079,600 5.58
Mar 14, 2014 5.60 5.68 5.53 5.63 4,479,200 5.63
Mar 13, 2014 5.71 5.74 5.55 5.65 3,830,100 5.65
Mar 12, 2014 5.65 5.72 5.58 5.69 4,087,900 5.69
Mar 11, 2014 5.78 5.82 5.55 5.65 7,328,600 5.65
Mar 10, 2014 5.69 5.85 5.60 5.71 5,649,000 5.71
Mar 7, 2014 5.77 5.80 5.58 5.71 4,968,900 5.71
Mar 6, 2014 5.94 6.04 5.68 5.71 8,098,600 5.71
Mar 5, 2014 6.12 6.14 5.88 5.89 7,881,000 5.89
Mar 4, 2014 6.09 6.19 5.96 6.08 8,215,600 6.08
Mar 3, 2014 6.10 6.17 5.94 6.13 8,795,400 6.13
Feb 28, 2014 6.26 6.34 5.94 6.19 8,333,500 6.19
Feb 27, 2014 6.45 6.46 6.20 6.39 5,570,800 6.39
Feb 26, 2014 6.61 6.62 6.33 6.48 5,507,800 6.48
Feb 25, 2014 6.50 6.66 6.39 6.54 10,142,300 6.54
Feb 24, 2014 6.08 6.50 6.06 6.40 10,320,900 6.40
Feb 21, 2014 5.96 6.13 5.96 6.02 6,177,200 6.02
Feb 20, 2014 5.98 6.09 5.81 5.96 8,164,300 5.96
Given on the number of researchers affiliated with both Mannkind and Johnson & Johnson, I think Johnson & Johnson is a good guess for a partner or buyout.