Technosphere Technology

[oracle]

One of the Most important things that is ALWAYS overlooked on the debate on AFREZZA is that IT DOSEN'T HAVE TO BE REFRIGERATED!

So the quality of life for Diabetics will improve ten fold as they won't need to worry about how to keep their insulin cooled until needed, such as when going out for dinner at poplar restaurants with long waits and/or slow service which really makes it difficult to calculate when to inject.

[alcc]

GREAT point, Oracle!

[oracle]

Then there's this:

The data show that 20 U or 22 U insulin using DPI 2 delivered similar exposures of insulin and FDKP compared with 30 U of insulin administered with MEDTONE®


Just imagine what it's worth to a BP if they can reduce their mfg. costs by 30% on all of their other drugs and vaccines by using Technosphere.....Imagine.

[jonnygambler]

Can anyone answer why Summer Street Research Partners claims this:

The Medtone C arm efficacy matters a lot. According to
clinicaltrials.gov, the primary endpoint of the AFFINITY 1 trial was: “Effect of
treatment as measured by change in glycated hemoglobin (HbA1c):
Comparison of baseline HbA1c to end-of treatment HbA1c after 24 weeks.”
The primary endpoint relates to a comparison of all three groups. The FDA is
extremely concerned about hypoglycemia and cardiac events associated with
diabetic medicines. Applications need thousands of patients treated before
the FDA will generally approve a drug for diabetes. Only a few hundred
patients have been treated with the Dreamboat inhaler. MNKD needs to use
the safety database of thousands of patients who have received Medtone C. In
order for the FDA to allow the use of the Medtone C inhaler safety data,
MNKD must show the Dreamboat is equivalent to the Medtone C inhaler.
 MNKD ignored the Medtone C arm efficacy results. MNKD
presented the numerical results from two of three arms from the AFFINITY 1
trial but refused to present the results from the Medtone C arm when asked
on a conference call. Furthermore, the press release elaborated on the less
important (secondary endpoint) comparison of pulmonary function between
the Dreamboat and Medtone C arms but was silent on the more important
(primary endpoint) comparison of hemoglobin A1c (a marker of glucose
control) between the Dreamboat and Medtone C arms.
 FDA unlikely to approve Afrezza without more trial data. We
expect the FDA will not approve Afrezza because the Dreamboat and
Medtone C inhalers are not equivalent. Rather, we expect the FDA will
require data from several thousand patients receiving the Dreamboat inhaler
before approving Afrezza.

I'd like to understand if this is truly meaningful as other analysts don't even mention this issue.
Thanks

[liane]

Personally, I think Summer Street is a bunch of BS. Afrezza the drug has been evaluated in thousands of patients. The current bridge study for comparisons of the inhalers was designed with input from the FDA to meet their requirements. I'm not worried, but you can make of it what you will.

[ashiwi]

It's not truly meaningful. Just misleading propaganda by a paid short. Afrezza trials met all end points with FDA and MNKD woring together. Afrezza is safe and will ultimately be one if the best selling medical products of all time.

[jonnygambler]

why do you think mnkd has not revealed the data from the Medtone C arm? Why is it not important?
Just trying to understand

[ashiwi]

This was found on The Fly on the Wall site from July 2013

09:31 EDT MNKD, PFE Afrezza sales could be higher than Exubera, says Summer Street
Summer Street believes that if approved, sales of MannKind's (MNKD) inhalable insulin Afrezza could be "substantially higher" than Pfizer’s (PFE) Exubera given Afrezza’s ease of use. However, the firm adds that it cannot accurately predict future sales of Afrezza at this time.

[jonnygambler]

I found this from Phaty

From MannKind Website Media FAQ:
2. There have been reports circulating that you withheld data from the Affinity 1 trial, specifically surrounding efficacy of the MedTone inhaler. At least one purported analyst found this “suspicious” and even “unprecedented”. Can you comment? Efficacy of the MedTone inhaler was never an endpoint of the that study. MedTone was included in the Affinity 1 trial at the FDA’s request in order to perform a head-to-head comparison of the pulmonary safety data for MedTone compared to the Gen2 device. Comparable pulmonary safety results would allow us to bridge the Gen2 device to the extensive safety data that we collected in our earlier clinical studies using the MedTone inhaler. As we reported in the conference call, the Gen2 and the MedTone groups in the Affinity 1 studies demonstrated a similar safety profile, thereby meeting this important secondary endpoint of the study. It would be highly unusual to include data of a regulatory trial that is not a defined key component of a study in “top line” results, which by definition only focus on important elements. That was why we did not publish the efficacy data for the MedTone group. Even so, when asked about those results during the conference call, we replied that the performance of the MedTone and the Gen2 devices were comparable and we do not see any appreciable difference between the two. In fact, the actual difference in mean HbA1c between the two inhaler groups was only 0.08%, which was not significant. This measure for both inhaler groups was non-inferior to that for the injected insulin control arm. This was not surprising, given that we had previously shown that the two inhalers were bioequivalent. It is disheartening that anyone who holds themselves out to be an analyst would use subjective and alarmist language with respect to such a minor result, or if they were confused, would not at least contact us and ask about it before publishing misinformation of this kind