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Post by lakers on Dec 1, 2015 13:03:03 GMT -5
I posed the question as either a possibility or not a possibility. Matt is intelligent enough to understand my question. If Sanofi could not seek EU approval based on the 2 completed studies, I would have expected: not possible or no reply. The fact he wrote it is a possibility indicates Sanofi either has or will apply for approval. That's the correct read. Sanofi will notify Mnkd right after its EMA MAA filing. Many analysts agreed that this would be a major catalyst. Btw, EU is not the only new Territory. Think Broad!
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Post by Deleted on Dec 1, 2015 13:11:40 GMT -5
I posed the question as either a possibility or not a possibility. Matt is intelligent enough to understand my question. If Sanofi could not seek EU approval based on the 2 completed studies, I would have expected: not possible or no reply. The fact he wrote it is a possibility indicates Sanofi either has or will apply for approval. That's the correct read. Sanofi will notify Mnkd right after its EMA MAA filing. Many analysts agreed that this would be a major catalyst. Btw, EU is not the only new Territory. Think Broad! In your opinion, has Sanofi filed or will they file soon in the EU? What countries could accept FDA approval for their approval?
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Post by factspls88 on Dec 1, 2015 13:13:00 GMT -5
That's a correct read. Sanofi will notify Mnkd right after its EMA MAA filing. Many analysts agreed that this would be a major catalyst. Btw, EU is not the only new Territory. Think Broad! Hi Lakers, I'm not familiar with the EU approval process. Once the filing is made, do you know typically how long the approval process is? Is there any fast track for FDA approved drugs? Also, am I correct in assuming that this will be a material event that requires notification to mnkd stockholders? Many thanks. facts
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Post by mnholdem on Dec 1, 2015 13:16:20 GMT -5
I posed the question as either a possibility or not a possibility. Matt is intelligent enough to understand my question. If Sanofi could not seek EU approval based on the 2 completed studies, I would have expected: not possible or no reply. The fact he wrote it is a possibility indicates Sanofi either has or will apply for approval. That's the correct read. Sanofi will notify Mnkd right after its EMA MAA filing. Many analysts agreed that this would be a major catalyst. Btw, EU is not the only new Territory. Think Broad! I'm thinking about broads all the time...
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Post by jeremg on Dec 1, 2015 13:18:20 GMT -5
What you actually did is set yourself up for a confirmation. Unfortunately, Matt would not be able to answer such a question [regarding EMA application] so I asked it in a way that he could. And you interpreted this as positive. 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. In one case you made a very positive interpretation. The fact he wrote it is a possibility indicates Sanofi either has or will apply for approval. This logic is flawed, in my opinion. It is a classic "leap to conclusion". The problem that I see is that anyone would have been able to tell you the situation you described is a possibility. You are well-researched and consider it a possibility. I am well-researched and consider it a possibility. But there are tons of permutations of the situation which would yield the same response as what Matt gave you. Sanofi could apply for EMA approval without the studies. Sanofi could wait until the pediatric study is complete. Sanofi could wait until the studies are actually published. The safety study could be started without EMA approval. It could occur on multiple continents. There is nothing terribly unique about the current state that is now permitting Sanofi to apply whereas they could not have applied in a state prior to this. There might be more strength behind their application with the recent study completions, however. I appreciate that you share your communications with management and that you are excited about the possibility of EMA application. I am excited too. My intentions here are to share my interpretations of information and put them out for questioning from the community and those that I trust and respect. I try to be objective and rational and promote those ideals to others. Hopefully this thread can be salvaged from the personal attacks and we can get away from the messages that belong in bathroom-stalls and not serious investor boards. Thank you for addressing this in a much more reasonable and logic based way, my patience with some of what I see here is "non-existent" at this point. You took the words right out of my mouth. "What you actually did is set yourself up for a confirmation." - And here lies the crux of the issue. "This logic is flawed, in my opinion. It is a classic "leap to conclusion"." - You truly have a way with words.
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Post by nemzter on Dec 1, 2015 13:30:21 GMT -5
That's the correct read. Sanofi will notify Mnkd right after its EMA MAA filing. Many analysts agreed that this would be a major catalyst. Btw, EU is not the only new Territory. Think Broad! I'm thinking about broads all the time... Definitely a possibility for the shareholders buyout celebration meeting in Vegas next year - or bust (Siberia)
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Post by stevil on Dec 1, 2015 13:31:58 GMT -5
my only question is why all the secrecy? What and who does it benefit? I'm sure if businesses were interested in the goings on of their competitors, they would pay people to do all the digging you all have done, all while probably having access to better information.
Why would it be so hard to say, "our plan is to apply for EU approval by January, or whenever we feel it will get approved by ____?"
I'm kinda new to this territory, so I'm not sure why being so tight-lipped all the time is beneficial. Again, it's not like we're the only ones aware of Afrezza and its capabilities. Is SNY afraid their plans will be thwarted and the right people paid off if they tip their hand ahead of time?
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Post by dreamboatcruise on Dec 1, 2015 13:33:35 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. I won't read "evasive" into it, or least no more so than current laws about non-public disclosure would dictate, but I also wouldn't read too much on the other side either. All that his answer establishes is that your reasoning is not outside the realm of possibility... though it says nothing about probable or in progress. It would be nice to have more candid public discussions. It actually would not be good if Matt were revealing meaningful information in private emails... that is a violation of securities laws.
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Post by bradleysbest on Dec 1, 2015 13:35:31 GMT -5
I would think if they released info (EU, Japan approval, DTC etc...) it would create interest in MNKD for possible partnerships, buyout etc.... Maybe I am nuts!
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Post by silentknight on Dec 1, 2015 13:36:27 GMT -5
Denise123: How would anyone read my post and consider it bashing? I could also ask you how you can post time and time again how everything is going to be rainbows and lollipops. That knife cuts both ways. My post was pretty even keeled and neutral in my opinion. I'm not sure what agenda you have but you'll be hard pressed to explain how I intended to bash the company with my post.
But you want a capitulation, ok. Here's one. I have had my frustrations with management and yes, I wish things have gone better. Does that make me a basher by wanting the company to do a better job in communicating with share holders and analysts? I don't think so, but clearly you disagree. That's fine. I won't insult you or accuse you of being a pumper though. It's uncalled for. I happen to think it's possible to be critical of someone, or a company that I feel very strongly about, without wishing them harm. The fact that you and others on this is board carelessly accuse others of FUD for disagreeing with your rose colored glasses view is quite off putting.
I don't have an aversion to MNKD. Quite the opposite actually. I believe in the company and I believe in the product or I wouldn't have held shares as long as I have. What I do have is an aversion to seeing a considerable investment go underwater, regardless of the company involved. It is my belief that accountability to shareholders is important and should be expected. Those of us with money on the line with partial ownership of the company should demand performance. If you don't then you're wasting your time and money. I tend to believe quite strongly in MNKD and I believe it it much more now that Al is in charge than I did with Hakan at the helm. I'm actually buying a few shares here and there at the current levels. But like my other shares, I purchase them hoping (there's that word we use so much) and EXPECTING the stewards of my investment to create value for me. But that's just me. Thanks for your concern. Have a great day.
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Post by thekindaguyiyam on Dec 1, 2015 13:38:38 GMT -5
my only question is why all the secrecy? What and who does it benefit? I'm sure if businesses were interested in the goings on of their competitors, they would pay people to do all the digging you all have done, all while probably having access to better information. Why would it be so hard to say, "our plan is to apply for EU approval by January, or whenever we feel it will get approved by ____?" I'm kinda new to this territory, so I'm not sure why being so tight-lipped all the time is beneficial. Again, it's not like we're the only ones aware of Afrezza and its capabilities. Is SNY afraid their plans will be thwarted and the right people paid off if they tip their hand ahead of time? said by one standing in a cemetery with blood coming out of your eyes. What a statement that is from arriving in a white coat pretending to be a medical student who asked the question "why do longs believe in Alfred Mann as if he were a god". The real question is; Why do you continue to voice negatively as your constant along with 3 or 4 of your buddies who usually give you that thumbs up. As to your question "my only question is why all the secrecy?"; if you were an investor in biotech stocks you'd know the answer to this question. You are simply unbelievable. "I'm kinda new to this territory, so I'm not sure why being so tight-lipped all the time is beneficial." As one who claimed to be a med student you'd have a good idea how biopharm works. Apparently you have missed those conversations in "med school". .
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Post by stevil on Dec 1, 2015 13:40:33 GMT -5
I would think if they released info (EU, Japan approval, DTC etc...) it would create interest in MNKD for possible partnerships, buyout etc.... Maybe I am nuts! That's what I'm thinking too... Unless you're saying that's why SNY doesn't want MNKD making announcements that would increase their value to inhibit competition and allow for a cheaper asking price?
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Post by bradleysbest on Dec 1, 2015 13:42:05 GMT -5
Who the heck knows at this point! This is one crazy investment..... Hoping for some good news soon!
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Post by stevil on Dec 1, 2015 13:50:38 GMT -5
You're gonna like this.
I actually had a biochem workshop today in which we tested the effects of 50g glucose drink, 2 hard boiled eggs, 4 dates, and about 12 ounce of orange juice on blood sugar after fasting 8 hours, then 20, 40 and 60 minutes postprandial.
We plotted the results from our class in an excel spreadsheet and made a graph. Guess what happened? The chart looked much like the PK profile of Afrezza.
So guess what I did? I told my teacher about it and told him to check out Afrezza. He said he hadn't heard of it yet but that he'd look into it.
If it makes any effect at all is questionable- I highly doubt my teacher will pimp it out to next year's class... but he might... but I thought I'd share that story with you because it talks about me being a med student, a long investor, and one who is telling others about Afrezza and getting the word out.
Have you told anyone about Afrezza yet today?
But let's not detract the others from this thread.
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Post by dreamboatcruise on Dec 1, 2015 13:52:21 GMT -5
stevil... I agree. I can see some areas where public disclosure might not be wise, such as with regard to negotiation with insurance payers, but the degree of silence currently I think could have negative influences even within the clinical community. SNY/MNKD are allowing the ghost of Exubera to haunt the Afrezza launch. If you're an overworked doc are you going to spend time learning to prescribe Afrezza (perhaps acquiring spirometry equip and learning to use it) if there are swirling rumors that Afrezza will go the way of Exubera. Silence at the beginning of the launch when it could be interpreted as not wanting to give away their brilliant plans for a blockbuster roll out is different than silence during a time when the common wisdom is that it is a failed launch and talk of break-up abound. I can't imagine that open discussion of timing for additional trials and expansion to other countries would be a net negative at this point even for SNY.
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