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Post by Deleted on Feb 25, 2016 20:58:14 GMT -5
But if you look at the past 30 days, you get this: Biotechs in general (IBB): DOWN 8.97 percent MNKD: UP 44.79 percent Dont compare the past 30 days. Compare the past 6 months. You are using the 30 days to support a prettier picture. |
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Post by cretin11 on Feb 26, 2016 5:50:55 GMT -5
This is on their lawyers though or not paying for top notch lawyers. I cannot imagine a change in management clause not thrown into the contract. These guys should cover all angels. This was beofre my time but weren't trials set up poorly to show superiority and that was on MNKD reverselo, are you aware of other deals like this that have included a change in management clause? |
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Post by Deleted on Feb 26, 2016 7:41:20 GMT -5
This is on their lawyers though or not paying for top notch lawyers. I cannot imagine a change in management clause not thrown into the contract. These guys should cover all angels. This was beofre my time but weren't trials set up poorly to show superiority and that was on MNKD reverselo, are you aware of other deals like this that have included a change in management clause? No clue totally assuming. Have zero experience in the situation and this is 100% my opinion. Have a lot of lawyer friends and a business and its just the difference between a good lawyer and a stud |
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Post by cretin11 on Feb 26, 2016 8:09:12 GMT -5
Such a contractual clause is quite possibly unheard of in the industry, in which case it wouldn't matter if MNKD had a good lawyer or a "stud" lawyer, because SNY simply wouldn't agree to it. You don't slip contractual clauses like that into deals without the other party noticing.
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Post by mnholdem on Feb 26, 2016 8:16:44 GMT -5
I have to respectfully disagree, and I think Matt even made reference to the mistakes that were made in the contract w/sny. From day one of the contract with SNY I have been harping about having signed an exclusive contract with total lack of product control, and the lack of documented contractual commitment on behalf of sny. The contract was signed with the assumption that SNY would do what they said however the contract didn't bind them to any time line, committed sales, agenda for marketing...This in itself is a huge boo boo on managements part and it's what put us in the position we are today. I can't speak to why the other companies you have mentioned have had such poor performance, I think Janet Yellen's comments about there being a bio-tech bubble sure didn't help. With that said, everyone makes mistakes, I don't know who dropped the ball on the sny contract and at this point it really doesn't matter, what does matter is what they do going forward. I believe they are capable of righting the ship if they make smart decisions and sign good contracts. This is on their lawyers though or not paying for top notch lawyers. I cannot imagine a change in management clause not thrown into the contract. These guys should cover all angels. This was beofre my time but weren't trials set up poorly to show superiority and that was on MNKD
Actually it was on the FDA and they took quite a bit of heat at the April 1, 2014 ADCOM hearing because of their decision to NOT demonstrate superiority. @reverselo since you state that some trial info "was before my time" here is part of the transcript where the FDA's logic for not setting up superiority studies was questioned:
1 DR. CALHOUN: Thanks. Bill Calhoun. I
2 have two questions for Dr. Yanoff and one for Dr.
3 Paterniti. First question for Dr. Yanoff. You
4 also commented on your Slide 22 that this was an
5 unblended study. It's a non-inferiority, and so
6 errors in -- or limitations in the execution of
7 this study will bias toward no difference, which,
8 in fact, as we heard this morning, then favors
9 finding a non- inferiority finding as opposed to a
10 superiority study, in which the bias toward the
11 null is a conservative approach.
12 The question is the FDA's been working
13 with the company for five years, by my count, in
14 pulling this product to market. And so the
15 question is was the agency responsible for
16 recommending a non- inferiority, unblended design
17 for the primary efficacy study?
18 DR. YANOFF: Yes, FDA was involved, me
19 personally, after the first submission, in
20 recommending the trial designs for the two studies
21 that they -- we wanted them to come in with the --
22 with the two new devices. And since we wanted to
Meeting 04-01-2014
(866) 448 - DEPO
www.CapitalReportingCompany.com © 2014
203
1 try to limit it to two studies, one in type 1 and
2 type 2, because we already had some data with the
3 MedTone device, we really had to go for what would
4 be the best trial for each type of diabetes. And
5 in type 1, a placebo-controlled trial would be
6 non-ethical, so
7 DR. CALHOUN: And explain to me why that
8 is? Because that would be an injection -- the only
9 thing it would add would be an injection of
10 placebo in those people who are randomized to
11 active inhaled drug, and the addition --
12 DR. YANOFF: Right.
13 DR. CALHOUN: -- of a dummy inhaler to
14 those who were getting injected -- and that's
15 certainly not -- in my view, that's certainly not
16 unethical. We have trials that are far more
17 invasive than that --
18 DR. YANOFF: Uh-huh.
19 DR. CALHOUN: -- in other therapeutic
20 areas, so I don't think that's unethical at all.
21 DR. YANOFF: I appreciate your view. In
22 general, in the Division of -- in DMEP, we've
Page 204
1 approached all -- tried to be fair to all the
2 programs, and in general, our approach has been to
3 not require blinded studies for type 1 --
4 DR. CALHOUN: Okay.
5 DR. YANOFF: -- to require dummy
6 injections.
---
I hear it a lot that MannKind Corporation should be held responsible for poor trial designs/protocols, but it actually was the FDA that screwed the pooch. If management was guilty of anything, it would likely be akin to being fearful that Afrezza would ultimately be rejected if MannKind went against the wishes of the FDA by insisting on superiority protocols.
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Post by cretin11 on Feb 26, 2016 8:21:37 GMT -5
Thanks mnholdem, I figured somebody knowledgeable would explain the FDA's role in the non-inferiority issue.
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Post by Deleted on Feb 26, 2016 8:23:53 GMT -5
Such a contractual clause is quite possibly unheard of in the industry, in which case it wouldn't matter if MNKD had a good lawyer or a "stud" lawyer, because SNY simply wouldn't agree to it. You don't slip contractual clauses like that into deals without the other party noticing. If you work in the industry and a clause like that is ridiculous then I guess it supports I have no idea what I am talking about...lol I just know great lawyers cover all of their basis. |
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Post by Deleted on Feb 26, 2016 8:26:46 GMT -5
mnholdem- Thanks for the information. I had asked abotu this in the past on here and knew the FDA botched things but not the specific details. However, I thought someone mentioned that Hakan admitted they would have liked to do things dfferently and they made some mistakes also.
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Post by stevil on Feb 27, 2016 17:31:06 GMT -5
I have to respectfully disagree, and I think Matt even made reference to the mistakes that were made in the contract w/sny. From day one of the contract with SNY I have been harping about having signed an exclusive contract with total lack of product control, and the lack of documented contractual commitment on behalf of sny. The contract was signed with the assumption that SNY would do what they said however the contract didn't bind them to any time line, committed sales, agenda for marketing...This in itself is a huge boo boo on managements part and it's what put us in the position we are today. I can't speak to why the other companies you have mentioned have had such poor performance, I think Janet Yellen's comments about there being a bio-tech bubble sure didn't help. With that said, everyone makes mistakes, I don't know who dropped the ball on the sny contract and at this point it really doesn't matter, what does matter is what they do going forward. I believe they are capable of righting the ship if they make smart decisions and sign good contracts. I agree with both this and mnholdem 's argument. Where we are since the SNY split is not management's fault. The market as a whole has been in a slump. It was going to happen regardless. However, added onto what jurystillout said, it's also on management that we are cash-poor and still have yet to sign a good TS deal. So many people seem to forget about our "embarrassment of riches" sitting in our vaults. If ever a case of self-indictment is to be made, Matt couldn't have said it any better. No one is to blame for where we are besides management. The fact that we're even in the position of putting all of our eggs into the Afrezza basket after 19 years of existence should tell you all you need to know about management. Many, many, many mistakes have been made along the way. |
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Post by als57 on Mar 2, 2016 10:00:45 GMT -5
When all is said, what has been done is " Robbery without a Gun!" All of the praises to the new CEO and his staff, but what has Matt done other than welcome comments - of NO consequence, yet in the blink of the eye, many options at very low exercise prices are granted. The question becomes "for what" especially if the Afrezza brand or the company is sold after 4/5 and the pps is elevated, is it not instant bonanza for the option holders? There hasn't been any marked improvement in the company's position, and moving the time hand back a year or so, didn't company officers, especially Matt have a platform for expressing concerns over aspects of the rollout that were negatively affecting Mannkind and its financial position.
The cluster fck over hiring a new CEO and then finding out that there was a "non-compete" stipulation attached! What kind of even cursory inquiry had been done with his previous employer?
As the doors of success have been shut by Sanofi's "poisoning the well" on Afrezza, then sale of one or both Afrezza and company, then the "golden highway" is assured for management with the stock options.
Regards, |
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