There are a lot of good post on the board about expectations. The lastest pointing out that we are in the final stages but no BP. No regionals either when according to management there was great interest. I definely think something is in the works behind the scenes. This is very telling.
"Expect the Unexpected" and wait for ADCOM, it will clear up alot of expectations. They next 2 weeks are going to be a wild ride. An exit now and you may not get an reasonable entry post ADCOM.
This is true, DF converted the first tranche of 40million to just under 8 million shares. My post was in reference to a discussion between pfg and myself concerning the amended agreement of feb28 which allowed for more conversion and when it can be accomplished.
I am just a bit unsure since its pursuant to the amendment. The terms of the amendment are clear in that its dependent upon FDA approval. I wish you were correct in that it would be extremely bullish. I think the conditions of the amendment must be met even though it was effective in February. Managements only requirement is to file the shares in order to be sold at this time. Thanks for your input I do appreciate your knowledge of the subject.
Deerfield is prohibited from conversion!
From the 10K:On February 28, 2014, we entered into a First Amendment to Facility Agreement and Registration Rights Agreement with Deerfield to provide for the
issuance pursuant to the Facility Agreement of tranche B notes to Deerfield in a maximum principal amount equal to (x) if the FDA approves the NDA for
AFFREZZA and Deerfield purchased the fourth tranche of 2019 notes,...
Only after approval will this possible take place.
If I'm wrong please advise.
Yea, but here in perpetual groundhog day it more like you don't have enough Euro theater points and now have to go to the pacific! Soon this will end as well!
I fully agree. If you were to estimate sales based on type 1 users, I would say the expectations may be in line. I generally feel that people underestimate the potential of this drug in the type 2 setting which is about 7x larger than the type 1 market. Im not saying it will but it has the potential to displace metformin as the first drug used.
My understanding is that the FDA is providing a free live broadcast of the event. But it never hurts for someone to give a personal insight on the body language and what may not be heard on the live broadcast.
Kevin, Perhaps I'm wrong. Deerfield has converted the first 40 million. This was fully completed end of December and beginning of January. The amended agreement to allow any more conversion is dependent on approval and only if MNKD takes the next 40 million Tranche.
If it is safe. If it is effective. If it expands insulin treatment to a subpopulation which is non compliant due to the stigma of needles. If it opens the realm of new future innovative treatment (artificial pancreas). If by its presence, it instill competition to investigate new ultra fast acting insulin's. If it challenges research to improve current basal therapy. If it potentially decreases the morbidity and mortality of the disease as well as exposure to less safe regimens. I for one cannot see how the FDA will stand in its way. Actually they should be doing everything in their power to pave its way. Without exception, researchers, patients and treatment providers want this drug. Hedge fund managers and analyst content with placing their money on the status quo are the only ones who do not.
Sorry, I misunderstood what you were trying to get across.
The incidence of severe hypos was reported as an incidence of 100 subject months. What ever the math what we should focus on is that the incidence of severe hypos was relatively low. The gen 2 group incidence was almost half of that reported in the injectable group. If indeed the majority of the incidence reported in the Gen2 group is attributed to a single participant if could establish the data as statistically significant. Could be a major point for the label.
seriously, isn't the credibility of AF somewhat tainted since there is some kind of personal grudge between him and Al Mann? Did not something happen between the 2 men a long time ago?
Does anyone remember specifically what transpired?
I'll take a stab at this. The shorts, as the rest of us were given the A1C results. You can interpret them any way you wish, but it in both studies they met the FDA endpoints.
What they were not given was the serial timed glucose measurements which will show better post prandial glucose control over injectable without the massive peak and valley effect that injectable are noted for (swings). With data bridge, previous studies are as relevant as 171 & 175. The FDA as well as Adcom cannot just choose to disregard! You get confirmation of Afrezza role in the cephalic phase, something that no, ZERO, injectable insulin has been able to replicate. Remember, this is an amended NDA of which the door was opened.Of course JMHO.
If memory serves me the remark you refer to was in reference to the time Al sold them the insulin pump. His remark indicated that at that time they were not interested in the drug market. It actually opened speculation they may be interested now.
I would not give a thumbs down at all. Its an option, but as I stated you will see MNKD sold to a foreign competitor. BP loses.
Several years ago Al was at a presentation given by Margaret Hamburg and other FDA types. Not that he put her on notice but he did state the fact that an FDA unwilling to assume some risk in approving innovated drugs would result in potential innovators leaving the US. In more recent times Al was invited to present to a group of Chinese physicians as a guest of China. To say they were interested would be an understatement. I don't believe this went unnoticed. Not that China would be a buyer because it could as well be India, Israel or India.
My belief, is the game has been played to completion. The FDA will approve this innovative and groundbreaking treatment because MNKD has fulfilled and met every road block placed in front of them that has either been deserved or undeserved.