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MNKD volume at 1 hour of trade,
real time, 190,462
summary,191,629

low, low volume.

$5.22. -0.03. (-0.67%)

The big movers today, MSFT and TSLA giving up some gains.

Nasdaq
11,976.15
-137.64(-1.14%)

I like that we’re adrift in the $5s instead of the $4s, but I do not have much confidence about a big bump in share price as a lead up to the next earnings report or afterwards with a new floor in the $6s or higher.  I think that would require an optimism coupled with speculation.  I think optimism is growing with respect to MNKD, but the market is losing its appetite or tolerance for speculation and will be more inclined to value companies on fundamentals.  I think this cautious outlook is also an inhibiting factor for technicals that doesn’t show up in the charts which predict future behavior on the past without (I assume) an input for investor market bull/bear sentiment.

I will be delighted to be wrong.

MNKD volume at 1 hour of trade,
real time, 230,853
summary,229,744
Avg. Volume 4,285,395

$5.14. -0.02 (-0.48%)

A lot of minor wording changes and clean ups generally. This page has all the links:
www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022472

Looking at the letter it's a notification that the waiver to only have a 1/2 page highlights section has expired and some minor changes. Since the highlights has been longer than a 1/2 page for a while now that bit is redundant! They have removed duplication between the highlights and the black box.

The dosing section has changed from this:

-----------------------DOSAGE AND ADMINISTRATION----------------------

 Administer using a single inhalation per cartridge (2.1)

 Administer at the beginning of a meal (2.2)

 Dosing must be individualized (2.2)

 Before initiating, perform a detailed medical history, physical

examination, and spirometry (FEV1) in all patients to identify potential

lung disease (2.5)

to this:

-----------------------DOSAGE AND ADMINISTRATION----------------------

• Only administer via oral inhalation using the AFREZZA inhale
(2.2)

• Administer at the beginning of each meal (2.2)

• See full prescribing information for the recommended starting

mealtime dosage in insulin-naïve patients and patients who are

using subcutaneous mealtime insulin or pre-mixed insulin (2.3)

• Modify dosage based on the patient's metabolic needs, blood

glucose monitoring results, and glycemic control goal (2.3)

• If blood glucose control is not achieved in patients requiring high

AFREZZA doses, consider discontinuing AFREZZA (2.4)

They have removed this bullet from the Warnings and Precautions (which makes sense since it's directly addressed by the black box):

Acute Bronchospasm: Acute bronchospasm has been observed in

patients with asthma and COPD. Before initiating, perform spirometry

(FEV1) in all patients. Do not use in patients with chronic lung disease.

(2.5, 4, 5.1)

as well as a bullet saying be careful when you change insulin types.

The Full prescribing information section has been somewhat reordered but on a (very) quick scan I can't see anything significant. Notably the RAA to Afrezza conversion chart is unchanged.