Diabetic Investor's Kliff on MannKind: 'Boringly Predictable'

Tickers in this article: MNKD

 

VALENCIA, Calif. ( TheStreet) -- MannKind () announced Monday the resubmission of Afrezza to the FDA, setting up another approval decision for the inhaled, rapid-acting insulin product in April of next year. 

FDA has already rejected Afrezza twice. The resubmission is based on new Afrezza clinical trials conducted by MannKind. The results from these new studies, announced in August, were controversial, to say the least .

Here's Diabetic Investor  David Kliff's take on MannKind's Afrezza resubmission:

This morning MannKind (MNKD) announced they have resubmitted the new drug application (NDA) for Afrezza. According to a company issued press release; "The resubmission is based on the entire data set from the extensive AFREZZA clinical development program and particularly the positive results from two recent Phase 3 trials, one in patients with type 1 diabetes (study 171) and one in patients with type 2 diabetes (study 175). Now as sure as day turns to night, talk will turn to how an approval, by no means a certainty, will impact the market.

Already this news is helping shares in the company which were once on a tear but over the past few months have seen a rather dramatic pullback. Now for anyone who's followed the company this is hardly surprising as shares in MannKind seem to be on a constant roller coaster with just as many thrills. Truth be told, any investor with the insight or a very strong stomach for risk who played the many ups and downs of these shares is likely very happy. Looking at chart of where these shares have been over the past two years makes MannKind the poster child for how investors can make money either being long, short or both.

Should the company follow its standard playbook this news will likely once again reignite talk about a possible partnership. Now the company has not yet announced the date they'll report third quarter earnings but whenever it is take it to the bank that somewhere during that call the company will mention they are talking with several possible partners or someone listening to the call will ask how this news is impacting partnership talks. If nothing else these quarterly calls have been becoming boringly predictable.

The real news is that today's announcement really isn't news at all and in fact does nothing to change the future outlook for the company. Let's assume for a moment that everything actually goes well for the company and that Afrezza is approved by the FDA and that by some miracle the company actually does find a partner. What happens then? Not much if you look at the market realistically. Yes it is true there will be some early adaptors who will use Afrezza but Diabetic Investor suspects the reception for Afrezza will be somewhat muted.