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Post by Deleted on Dec 1, 2015 8:45:04 GMT -5
I emailed Matt the following question:
Matt - I know this is a question for Sanofi but I am hoping you can at least acknowledge if the following assumption is correct. With the 2 studies completed, one would think Sanofi could apply for EU Afrezza approval for adults while pediatric study is under way. If the EU approved Afrezza for adults, then the 8000 safety trial could be conducted on both continents. Is my reasoning within the realm of possibilities? If you can not talk about it, could you at least acknowledge that?
Below is Matt's response:
"It is indeed within the realm of possibility. But the safety study could be done on multiple continents regardless. We did our phase 3 studies on three continents."
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Post by bradleysbest on Dec 1, 2015 8:52:13 GMT -5
Let's hope someone (SNY or MNKD) communicates with us that your assumption is true & if a FDA label change is in the process. It does seem like there will be some good news soon for us longs.....
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Post by cathode on Dec 1, 2015 8:57:07 GMT -5
Thanks for sharing your communications @kastanes
I think a more pointed question/comment would be "if the EMA approves Afrezza for adults and requires a long-term safety study post-approval, could SNY design a single study that addresses the needs of both the FDA and EMA?"
It seems to me that your current question, which he answers directly, is whether safety studies could have participants from multiple continents.
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Post by Deleted on Dec 1, 2015 9:13:55 GMT -5
Matt answered the EU approval possibility with the 2 studies completed and addressed the safety trial question. Every time I post Matt's response to one of my questions, people look for ways that he is being evasive. If you are long, I would take Matt's response as a positive to EU approval possibility, and not read more into it than that.
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Post by Deleted on Dec 1, 2015 9:18:18 GMT -5
Matt answered the EU approval possibility with the 2 studies completed and addressed the safety trial question. Every time I post Matt's response to one of my questions, people look for ways that he is being evasive. If you are long, I would take Matt's response as a positive to EU approval possibility, and not read more into it than that. approval with out applying? should have asked directly.. if a EMA application was filed?
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Post by bradleysbest on Dec 1, 2015 9:24:35 GMT -5
I doubt he would give a direct answer.... Not the way MNKD operates!
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Post by rrtzmd on Dec 1, 2015 9:40:19 GMT -5
I emailed Matt the following question: Matt - I know this is a question for Sanofi but I am hoping you can at least acknowledge if the following assumption is correct. With the 2 studies completed, one would think Sanofi could apply for EU Afrezza approval for adults while pediatric study is under way. If the EU approved Afrezza for adults, then the 8000 safety trial could be conducted on both continents. Is my reasoning within the realm of possibilities? If you can not talk about it, could you at least acknowledge that? Below is Matt's response: "It is indeed within the realm of possibility. But the safety study could be done on multiple continents regardless. We did our phase 3 studies on three continents." "It is indeed within the realm of possibility" -- the usual Mannkind response which really tells you nothing at all.
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Post by dictatorsaurus on Dec 1, 2015 9:50:49 GMT -5
Everything is possible in life!
Simple question, did they file the application or not?
It's mind boggling we can't even get a simple yes or no.
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Post by Deleted on Dec 1, 2015 9:55:31 GMT -5
As usual, shorts distort every bit of positive information to fit their suppositions. EU is easily within the realm of possibilities and may have been already applied for, but that is Sanofi's responsible to disclose. Unfortunately, Matt would not be able to answer such a question so I asked it in a way that he could.
Longs, don't get discouraged, their are many good possibilities to look forward to. EU application would be a great one!
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Post by rrtzmd on Dec 1, 2015 10:19:02 GMT -5
As usual, shorts distort every bit of positive information to fit their suppositions. EU is easily within the realm of possibilities and may have been already applied for, but that is Sanofi's responsible to disclose. Unfortunately, Matt would not be able to answer such a question so I asked it in a way that he could. Longs, don't get discouraged, their are many good possibilities to look forward to. EU application would be a great one! No disrespect intended, but, in this case, I would argue that you are the one trying to "distort bit of positive information to fit their suppositions." Matt's response revealed nothing at all. If you had asked him whether he expected MNKD to get a $100 a share buyout bid tomorrow and got the same response, would you be looking forward to it right now?
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Post by thekindaguyiyam on Dec 1, 2015 10:34:03 GMT -5
As usual, shorts distort every bit of positive information to fit their suppositions. EU is easily within the realm of possibilities and may have been already applied for, but that is Sanofi's responsible to disclose. Unfortunately, Matt would not be able to answer such a question so I asked it in a way that he could. Longs, don't get discouraged, their are many good possibilities to look forward to. EU application would be a great one! No disrespect intended, but, in this case, I would argue that you are the one trying to "distort bit of positive information to fit their suppositions." Matt's response revealed nothing at all. If you had asked him whether he expected MNKD to get a $100 a share buyout bid tomorrow and got the same response, would you be looking forward to it right now? rrtzmd
No disrespect intended, but, in this and nearly every other case your negative twist makes me wonder why you own the stock in the first place. I see your posts and think "why is this guy wasting an enormous amount of time when he thinks the stock and the company are a bad investment?" When there are positive questions asked... that's ok even when the spokesperson won't provide shareholders "inside information" as a special favor to anyone who writes to him. That's the game of all Corporate Representatives... If I said the sky was blue, you'd argue that it was green. Kastanes I know to be honest. I can't say that about every poster on this board who continue to spew negative whenever the opportunity allows.
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fap
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Post by fap on Dec 1, 2015 10:49:57 GMT -5
I agree 100% with you thekindaguyiyam
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Post by ezrasfund on Dec 1, 2015 10:54:27 GMT -5
It is important to remember that Matt cannot give you even the hint of any information that has not previously been made public. He explained this point himself in one of the e-mail exchanges. The only time that his e-mail response would be enlightening is if you had missed or misinterpreted some of the public statements from the company. For those who follow the company closely and go over the filings and public statements with a fine tooth comb there is really nothing he can add without violating SEC rules. Statements such as "it is possible," "cannot be ruled out," or "not necessarily so" do not indicate anything but what might happen, and we already know that what might happen is anything from a buyout to bankruptcy.
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Post by silentknight on Dec 1, 2015 11:05:26 GMT -5
People can be optimists and people can be pessimists. I suppose it all depends on what your perspective is of how things have gone recently with MNKD management and their answers. Me, I consider myself a realist and try to view things with a bit of objectivity. The reality is that Matt's response tells us absolutely nothing. Saying something is "within the realm of possibility" is nothing more than another way of saying nothing at all. Maybe they've applied for EU approval based on the completed studies, and I certainly hope they have but Matt's response doesn't tell us that. It is "within the realm of possibility" that they have, but it's also "within the realm of possibility" that they haven't and to read into either of the two options without more information doesn't serve any purpose other than to feed an agenda, whether it be to pump or bash. I'd love to read into what Matt said as a positive, but it's just not there. I'll look forward to the day when Matt or Al definitively tells us that there has been progress on some front. They can't keep feeding investors and analysts non-answers and expect anything to change. We've recieved that since the partnership and look what we have to show for it. I get that they're bound by NDA's but say that and remove the cloud of doubt from the equation that MNKD is asleep at the wheel. Al's return as CEO helped do that but there has to be better communication from the company as well. The punishment that the market has delivered to the company in the last year is in large part to their inability to communicate effectively in my opinion.
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Post by hammer on Dec 1, 2015 11:06:42 GMT -5
Matt answered the EU approval possibility with the 2 studies completed and addressed the safety trial question. Every time I post Matt's response to one of my questions, people look for ways that he is being evasive. If you are long, I would take Matt's response as a positive to EU approval possibility, and not read more into it than that. Kastanes, Matt is an expert at only providing current public knowledge. I too have had some communication with him about prior statements. Most notably his conservative stance on the SNY LOC and whether he still considers the amount conservative and sufficient. His reply confirmed that in his estimation the LOC is sufficient although they have not sold at levels anticipated. He also mentioned that it is still early in the process. They also retain a level of optimism due to the responses they hear from patients. I take this response on face value only. Although, things are slow they are maintaining focus and expect success. I did feel encouragement in his response, at this point I will take anything I can get.
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