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Post by trenddiver on May 22, 2014 14:52:31 GMT -5
1. Things are proceeding normally and expeditiously with the FDA. They are working closely together towards approval. Hakan said there will be no more CRL letters.
2. They dont expect any problems with the FDA inspections of the Danbury facility which they are readying for production within 6 months of approval.
3. Insulin on hand is in good condition and being monitored. Apparently the FDA will have some say about how much of the insulin can be used. I might be wrong about this but they may be going forward with a newer form of insulin.
4. There are many other applications of the Technosphere platform that are being considered and explored by the company and potential partners. One application that Al mentioned was pain medicine.
5. Potential partners are not involved in any of the FDA discussions.
6. There are no discussions regarding the purchase of Mannkind, but the company certainly would look at offers if such were presented and evaluate them based on patients and shareholders.
7. There was virtually no discussion about Afrezza partnership at the meeting.
8. Deerfield has been very helpful and their interests are very much aligned with the company. e.g. Deerfield does not do real well unless Mannkind is successful.
Trend
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Post by zagorgordon on May 22, 2014 14:57:10 GMT -5
#5 is incorrect. They are involved but not directly with FDA.
#8 is made up. No one mentioned Deerfield.
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Post by trenddiver on May 22, 2014 15:03:54 GMT -5
Some of my takeaways were after the meeting in conversations with Mannkind employees - especially regarding Deerfield.
Also Hakan specifically said that discussions with the FDA were between Mnkd and the FDA. Expertise and advice regarding dealing with the FDA came from many sources including potential partners.
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Post by seanismorris on May 22, 2014 17:01:32 GMT -5
Are you able to clarify your thoughts on # 3
3. Insulin on hand is in good condition and being monitored. Apparently the FDA will have some say about how much of the insulin can be used. I might be wrong about this but they may be going forward with a newer form of insulin.
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I'd assume the second sentence is the FDA inspecting the facility which will also include the insulin...
The 'newer form of insulin' I would think would require a follow up study.
FYI: My thoughts on the next version of Afrezza
The Technosphere could technically hold additional drugs or other forms of insulin. For example, they could add a basal insulin (from a partner?). Or, they could add something to reduce the frequency of cough.
They could also reduce the average particle size (maybe related to cough).
In patents we've seen Mannkind increase the concentration of insulin within the Technosphere (to about 90% bioavailability of injected insulin vs. 30% in Afrezza).
Less powder = less cough (in the 12 unit cartridge it looks like they will be packing in more insulin, so the cartridge size doesn't change, they've said the 12 will take time to get approved -requires a study)
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Post by mrv on May 22, 2014 19:19:04 GMT -5
Thank you Trend for your notes.
Just a question re #8: Do you mean Greenhill, instead of Deerfield? Since Green will be compensated based on the partnership/buyout.
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Post by Deleted on May 22, 2014 20:28:33 GMT -5
Did anyone ask anything about Greenhill?
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Post by 4allthemarbles on May 22, 2014 23:12:10 GMT -5
Trend- nice recap. Also, thanks for taking the picture of Me and Al.
I also had something to throw in there. After the meeting I was speaking with Matt. From what I got out of the conversation, aside from the confidence regarding approval. It would take a minimum of a week to announce the partner (after they agree on one). There are already offers out there, so good ones. The feeling is they can get the optimal offer. Also, at this point in the game, Al is not involved wi the partner work (Greenfield has a job to do, but they are obviously not the final say).
Long story short- approval will bring very good offers that are acceptable, but they want what is best for the situation. Finding a partner and a good deal is not hard, it's the right deal. I don't think they are far off from that deal.
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Post by trenddiver on May 23, 2014 0:06:59 GMT -5
I did mean Deerfield. I was interested in the company's take on the short interest. So I asked about it and specifically asked whether it was likely that Deerfield had a large short position. The answer was that Deerfield has been helpful and flexible with financing as it relates to Mannkind's needs. The point was that Deerfield made a big bet with Mannkind and will make large returns if a Mannkind is successful. So the likelihood of a large short interest by Deerfield was not high.
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Post by trenddiver on May 23, 2014 0:20:07 GMT -5
Re#3
As to a the insulin, it was kinda weird. They've been saying along that they had all this insulin in safekeeping and someone raised the question about the insulin in the q&a. Specifically the question had to do with whether this insulin, which has been expensed for financial statement purposes should be reclassified as an asset if FDA approval was obtained. Matt said no, and Al broke in and said something about 10,000,000 doses for a year, and then they backtracked and started saying they probably couldn't use it all and that the FDA might have something to say.
So after the meeting I spoke to Matt and asked him what the replacement cost was of the insulin. He said something like 300 - 400 hundred million dollars. I was stunned that we had such a large "hidden" asset. And then he brought up something about a new insulin and the left to go off to a Board meeting. So that's the color.
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Post by mrv on May 23, 2014 11:58:48 GMT -5
Thanks Trend for the clarification.
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Post by seanismorris on May 24, 2014 0:02:08 GMT -5
Very interesting info on the insulin in storage. A quick search on the internet shows insulin is good for 28 days. Obviously, the insulin Mannkind has is an all together different animal. If I remember correctly Mannkind has said their insulin won't go bad before they use it all, but that was before the delays. Also, if the FDA determines some is 'bad' wouldn't they have to dispose of all of it? I assume most of the insulin was received in the last run up to approval.... Now, if when they are talking about 'new' insulin they mean 'better' insulin. I'd think the dosing would have to change, etc. I guess we will find out post approval.
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Post by liane on May 24, 2014 5:08:35 GMT -5
MNKD's insulin is is in the deep freeze - it is good indefinitely as such. The 28 day figure relates to insulin in solution and kept in the fridge. We did have a thread on this, but I don't have the time right now to search.
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Post by notamnkdmillionaire on May 24, 2014 8:38:08 GMT -5
MNKD's insulin is is in the deep freeze - it is good indefinitely as such. The 28 day figure relates to insulin in solution and kept in the fridge. We did have a thread on this, but I don't have the time right now to search. The FDA seems to think otherwise based on the comment made by management that they might not be able to utilize all that is in deep freeze. What I don't know is how long frozen insulin is deemed ok to use by the FDA. For example, frozen human plasma that is deemed ok to use for injectable uses after fractionation for proteins (F VIII, IX, IVIG, Albumin etc) is only good for 10 years from the date it was collected. Human plasma MUST be maintained in a temps of -20C or colder for storage. If for European use, the plasma must be initially frozen at -30C where as for US use at -20C. Yes, the EMA has some crazy rules. I have been in these freezers for extended times and they are frickin cold. Fans are always running to circulate air so it always feels colder than what it really is though -30 is cold even when the fans are off. The question is, "how old is the insulin that MNKD has and how long is frozen insulin deemed ok for use by the FDA?" I'll have to research that. |
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Post by liane on May 24, 2014 9:32:18 GMT -5
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Post by notamnkdmillionaire on May 24, 2014 9:49:29 GMT -5
Thanks. Unless I missed it, I don't see anything from that document that states "expiration" date for stored insulin. It only discusses the bioactivity/degradation of the molecule at a -20C. And because it's a WHO document, I don't know if the FDA follows the same guidelines. Different countries/agencies can have very different requirements. Frozen human plasma as an example. EMA is much more strict than FDA. And when MNKD gets EMA approval, they might have to change a few things to comply with EMA if regs differ than FDA. I'll see if I can get in contact with the FDA on Tuesday to see if they have guidelines on how long inhaled insulin is good for. It would really suck if MNKD ends up having to destroy a lot of their inventory because the FDA deems it expired. |
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