Post by mannmade on Mar 11, 2014 14:06:12 GMT -5
For those of you that choose to read the below list let me first note a couple of things:
1.) One I am a significant shareholder in Mannkind and have been following everyday for the last 4 years or so, (like many of you)
2.) With the recent stock performance I felt a need to go back though my notes (nothing better to do until April 1st) and compile a list of the various anecdotal pieces of information I have collected over the last four years and put into one list to create a clear picture of the reasons we all believe in this product and why it is likely to get approved.
3.) Please note I am not a licensed professional, nor am I a trader, I just believe like most of you and the below represents my personal opinion of why i think Afrezza will be approved by the FDA
4.) I am not a pumper, I am just trying to provide some factual information to counter all the negativity that we see which is generally unsupported by factual back-up
5.) If I have some mistaken information below please feel free to correct me as it certainly was not intentional
6.) Feel free to add your opinions or to the list if there is anything you think I missed
The whole point of this exercise is to see everything in one place and not to have these one off conversations about why it will be approved or not... GLTA
“Reasons Why Afrezza Will be Approved:”
1.) FDA previously approved Exhubera
2.) Al Mann has 1.2B of his own money in this company unsecured in common stock
3.) The head of Pfizer’s Exhubera Team said it will likely be approved
4.) 75% less hypoglycemia and
4b.) leaves no residue in the lungs
5.) FDA designed studies 171 and 175 with Mannkind asking for 175 and also research on use with children as young as 4
6.) Only needed to prove non inferiority and bio equivalence
. Very low thresholds for success.
7.) Afrezza met all the end points
8.) Deerfield loaned Mannkind 160m and did not have to pay second tranche unless it’s own independent review of the Phase 3 results made sense to them
9.) Deerfield fully converted the 2nd tranche of debt to mankind common stock and additionally recently agreed to convert another 60m with an additional loan of another 90m post approval
10.) Green Hill Partners accepted the representation of Mannkind on a success fee only basis and Sr. Management of Mannkind has repeatedly said they are very happy with their progress
. So not only is Green Hill confident it appears they have interested parties for a partnership (or buy-out) that are also expecting same.
11.) Mannkind has stated at this time they are not even looking at regional partners
12.) Ad Com gives the approval process significant transparency that was not part of previous crl’s
13.) Samsun has used Afrezza as part of the artificial pancreas studies it conducted.
14.) Dr. Fran Kauffman who is part of the artificial pancreas studies was previously involved with Mannkind
15.) Bill Doub, the FDA’s lead chemist has stated that inhalation delivery is the path the FDA is heading down and sees insulin as a big part of that future
16.) Faster activation for mealtime and less tail for last meal of day
17.) No needles (3x 365 = 1,095 less injections per year)
18.) No needles means less pain/more compliance, less risk of infection and no scarring at injection site
19.) Better compliance means less cost to health care system
20.) Does not need refrigeration, (think lunch on the go at work and 3rd world)
21.) Now being regarded as a first in class drug in a sector that has not seen such a disruptive product since the insulin pump
22.) Al Mann is currently scheduled to speak at ADA national conference in June
23.) PDUFA date has not yet been pushed back
24.) Additionally, Priced to be similar to insulin pen so will be covered by insurance
25.) Lastly, a Huge global need for a product that is clearly superior if all of the approve is correct.
One last.. because Spiro said so...
1.) One I am a significant shareholder in Mannkind and have been following everyday for the last 4 years or so, (like many of you)
2.) With the recent stock performance I felt a need to go back though my notes (nothing better to do until April 1st) and compile a list of the various anecdotal pieces of information I have collected over the last four years and put into one list to create a clear picture of the reasons we all believe in this product and why it is likely to get approved.
3.) Please note I am not a licensed professional, nor am I a trader, I just believe like most of you and the below represents my personal opinion of why i think Afrezza will be approved by the FDA
4.) I am not a pumper, I am just trying to provide some factual information to counter all the negativity that we see which is generally unsupported by factual back-up
5.) If I have some mistaken information below please feel free to correct me as it certainly was not intentional
6.) Feel free to add your opinions or to the list if there is anything you think I missed
The whole point of this exercise is to see everything in one place and not to have these one off conversations about why it will be approved or not... GLTA
“Reasons Why Afrezza Will be Approved:”
1.) FDA previously approved Exhubera
2.) Al Mann has 1.2B of his own money in this company unsecured in common stock
3.) The head of Pfizer’s Exhubera Team said it will likely be approved
4.) 75% less hypoglycemia and
4b.) leaves no residue in the lungs
5.) FDA designed studies 171 and 175 with Mannkind asking for 175 and also research on use with children as young as 4
6.) Only needed to prove non inferiority and bio equivalence
. Very low thresholds for success.
7.) Afrezza met all the end points
8.) Deerfield loaned Mannkind 160m and did not have to pay second tranche unless it’s own independent review of the Phase 3 results made sense to them
9.) Deerfield fully converted the 2nd tranche of debt to mankind common stock and additionally recently agreed to convert another 60m with an additional loan of another 90m post approval
10.) Green Hill Partners accepted the representation of Mannkind on a success fee only basis and Sr. Management of Mannkind has repeatedly said they are very happy with their progress
. So not only is Green Hill confident it appears they have interested parties for a partnership (or buy-out) that are also expecting same.
11.) Mannkind has stated at this time they are not even looking at regional partners
12.) Ad Com gives the approval process significant transparency that was not part of previous crl’s
13.) Samsun has used Afrezza as part of the artificial pancreas studies it conducted.
14.) Dr. Fran Kauffman who is part of the artificial pancreas studies was previously involved with Mannkind
15.) Bill Doub, the FDA’s lead chemist has stated that inhalation delivery is the path the FDA is heading down and sees insulin as a big part of that future
16.) Faster activation for mealtime and less tail for last meal of day
17.) No needles (3x 365 = 1,095 less injections per year)
18.) No needles means less pain/more compliance, less risk of infection and no scarring at injection site
19.) Better compliance means less cost to health care system
20.) Does not need refrigeration, (think lunch on the go at work and 3rd world)
21.) Now being regarded as a first in class drug in a sector that has not seen such a disruptive product since the insulin pump
22.) Al Mann is currently scheduled to speak at ADA national conference in June
23.) PDUFA date has not yet been pushed back
24.) Additionally, Priced to be similar to insulin pen so will be covered by insurance
25.) Lastly, a Huge global need for a product that is clearly superior if all of the approve is correct.
One last.. because Spiro said so...
