Post by LosingMyBullishness on Jun 16, 2018 7:52:01 GMT -5
Bill,
thanks for providing valuable content.
I will try to convert this pdf to search for specific references.
You found that
"During the second review cycle Dr. Theodore Carver concluded that “based upon the stability data submitted for the Gen2 product, a month shelf life for storage at 2-8o C is granted with an additional 10 days of storage at room temperature permitted before use or disposal of the Afrezza drug product.”
Now, have you seen the stability data that was submitted?
Now, have you seen the stability data that was submitted?
It could be that MNKD only provided stability data when refrigerated and NOT stability data when not refrigerated !
If so, the FDA had not the mandate to prove that refrigeration is not needed.
I mention this because I believe that Al did this statement because he had conducted tests. It would be highly illogical to come up with such an unusual statement w/o tests that backed it up.
We know that in the FDA application basically everything that could go wrong, did go wrong.
In 2015 Matthew Bendall from afrezzadownunder.com (this site seems to be discontinued, I believe due to costs and lack of support) but you can still find his videos on youtube.
He did a thorough test when he left Afrezza in a tropical garden, nicely packed in foil, for months and used exactly this Afrezza do to live tests. It worked perfectly.
--> There was no indication of a degration.
--> So we have
A) Al stating that refrigeration is not needed and my opinion that he would have never stated this without tests that confirmed this.
B) A guy that did in 2015 a self-test using Afrezza he stored for months that worked nicely
Why is this important:
A) Lack and costs of refrigeration chain in developing countries. If we talk about internation adaptation a US perspective with their huge fridges should not be generalized.
B) Handiness of Afrezza Usage while traveling. This helps to establish Afrezza in this niche application that generates growth.
Why this should be simple:
MNKD is often using the PK-graph to show the kinetics of Afrezza. There would be a period when you store Afrezza at different temperatures: This is very simple. No patients are involved. It is just a lab with some ovens.
After a certain time they would do tests with this Afrezza on patients checking their values using the latest recommentations.
After a certain time they would do tests with this Afrezza on patients checking their values using the latest recommentations.
THis is NOT a test that involved or tracks patients on a long-term. Long term is what Afrezza is stored. That's a totally different story.
What I thing of Matt's comment:
Why is Tesla successful and MNKD not?
Elon Musk solves problems by developing solutions. People in the automotive industry would have had the same quick answers about electric cars as were provided here or by Matt: "Not worth it, too expensive, does not work".