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Post by Deleted on Dec 1, 2015 13:54:04 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? so martins and stevil would write letters to influence the authorities - is one of my guess
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Post by cathode on Dec 1, 2015 13:59:24 GMT -5
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 don't really want MNKD management spending time dismissing rumors that the partnership is going to break up. There are obvious reasons they shouldn't do this. In the cases where they do address this (Q3 2015 ER CC), they are resolute in their message.
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Post by stevil on Dec 1, 2015 14:03:40 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. That's precisely my fear. I'm trying to stay a "realist", but I don't know which side to place certain things on the balancing scale. I would agree that if things are going poorly right now, no news is better than telling us this. Maybe SNY wasn't confident in the execution of their plan and had enough foresight to know that if they revealed too much and didn't make their expectations, it would be perceived as negative and would cause others to overreact? Is that kind of what you're saying? Because even then, just don't give timeframes. I'd just be content with knowing what the plan is. Then, when others ask about it in CC, you can just say "we're still working on it" or "it's still in process" I guess this dead horse has been pulverized by now, but I don't understand why we don't even know which direction we're currently headed. There are breadcrumbs to follow for those who want to dig up information anyway. Why not be just a little more transparent about it?
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Post by dreamboatcruise on Dec 1, 2015 14:13:38 GMT -5
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 don't really want MNKD management spending time dismissing rumors that the partnership is going to break up. There are obvious reasons they shouldn't do this. In the cases where they do address this (Q3 2015 ER CC), they are resolute in their message. I don't want them spending time addressing rumors either. I want them spending time discussing the future for the partnership and what is being done to make Afrezza a successful product... that would naturally leave no room for breakup speculation and thus no need to specifically address it. You wouldn't have an analyst asking about a breakup in a conference call if the public stance of SNY and MNKD were such that an analyst would look silly and or acting with an agenda by posing the question. Currently, posing that question seems reasonable to all too many. stevil... specific sales projections probably would not be (or have been) wise. At this point I think SNY needs to be publicly more supportive to show the medical community that they are behind Afrezza for the long haul. I've never expected them to be motivated to show public support in a way that is aimed at helping MNKD shareholders.
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Post by EveningOfTheDay on Dec 1, 2015 14:17:53 GMT -5
Yes, there are things Mannkind simply can not tell us. I think we all understand this. However, at present they stand out more for what they are not telling than for what they are. Some here want to believe that all this has a meaning soon to be revealed. Some simply think that the company could do a much better job at communicating what they can say and what they will not or can not say. To expect the company to comment on every single aspect of the agreement with Sanofi and their operations is completely unrealistic, but to expect that, in the odd occasion where the company chooses to communicate something, that something is relatively clear and that once said follow ups should ensue is completely reasonable.
Without being a basher, I am on the side that thinks the company has done a lousy job telling us what they can not say, what they can say, and following up on issues they have brought up in the past. Why it should be this way is what I, like many others, wonder about. Something absolutely normal considering the tumbling the sp has taken over the last year and how the many attempts to place Mannkind in a better financial situation have fallen short. If the questioning by some bothers anybody so be it, but please understand that in my humble opinion questioning is not bashing and should not shake any fundamental believes on anybody other than on those already grasping at straws. Therefore, to both, skeptics and believers, I would ask that as long as your comments are reasonable and devoted of personal attacks, you keep posting your opinions. At the end we all benefit from it, and since nothing we say here will change, as is perfectly obvious, the direction of the sp, at the end well based theories in favor or against should only benefit all of us and help us make smarter decisions in the future. With aloha to all.
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Post by lakers on Dec 1, 2015 16:24:53 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 There are excellent threads on this board on EMA, CHMP approval process. You can dig it up. The longest step takes 210 days max. It took Toujeo less than 2 months to get approved by EMA. Afrezza is different. EMA MAA filing Is normally considered material by many cos.
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Post by bradleysbest on Dec 1, 2015 16:25:58 GMT -5
Different in it could be faster than 2 months?
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Post by hankscorpio7 on Dec 1, 2015 17:10:59 GMT -5
I agree with kindaguy. There is no point furthering the management silence theme. Emailing Matt would also seem pointless. They have nothing they legally can say. Why open self up for litigation? It is all out there. We are fairly certain EMA was not started. Would Matt revealing this be useful? Even if it has, it will be a long process. It might mean SNY is committed, but it doesn't bind them to anything. Euro approval more likely to be a sell the news if scripts do not pick up. Look at KERX. It only rallied after further dilution. Things I am looking for: start of 8000 study, TV ads- how hard is it to advertise, really?-, change in insurance, or future dilution. Those will drive pps. Otherwise- prepare for silence and stagnation. SNY keeping Afrezza on the down low I interpret as not scaring away future partners in same space.
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Post by Deleted on Dec 1, 2015 17:22:58 GMT -5
Amusing how short sellers have moved from Sanofi ending the partnership to EU approval is meaningless. Soon January will be upon us and no news from Sanofi will end short sellers last supposition of ending the partnership
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Post by mssciguy on Dec 1, 2015 17:25:50 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. if there had been a diabetic in the class, maybe you could have done an extreme challenge a la Matt B down under.... he's a very clever guy.
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Post by trenddiver on Dec 1, 2015 19:43:23 GMT -5
I don't really want MNKD management spending time dismissing rumors that the partnership is going to break up. There are obvious reasons they shouldn't do this. In the cases where they do address this (Q3 2015 ER CC), they are resolute in their message. I don't want them spending time addressing rumors either. I want them spending time discussing the future for the partnership and what is being done to make Afrezza a successful product... that would naturally leave no room for breakup speculation and thus no need to specifically address it. You wouldn't have an analyst asking about a breakup in a conference call if the public stance of SNY and MNKD were such that an analyst would look silly and or acting with an agenda by posing the question. Currently, posing that question seems reasonable to all too many. stevil ... specific sales projections probably would not be (or have been) wise. At this point I think SNY needs to be publicly more supportive to show the medical community that they are behind Afrezza for the long haul. I've never expected them to be motivated to show public support in a way that is aimed at helping MNKD shareholders. Don't expect Sanofi to say anything about Afrezza, especially for the benefit of Mannkind or the medical community. This is just not their style.
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Post by cjc04 on Dec 1, 2015 20:08:17 GMT -5
Amusing how short sellers have moved from Sanofi ending the partnership to EU approval is meaningless. Soon January will be upon us and no news from Sanofi will end short sellers last supposition of ending the partnership Kastanes, I love ya man, but you need to read your posts once in awhile and realize the difference between proclaiming facts and just using emotion to take the other side.... It really discredits the fact finding work you do. I want to jump on board with everything you say, but my own fantasies have gotten me in the hole I'm in with this company and I'm doing everything I can to stay focused on details and very minimal dot to dot connecting, and I'm only doing that because we've been left with nothing else..... The problem I have with this post is... Discussing the possibility of SNY ending the agreement in January doesn't make someone a short, hell it's what keeps ME up at night and if I'm dot connecting the dots may line up to that happening... Also, just because SNY doesn't notify to terminate In January that doesn't mean we're home free.... I'm not trying to come down on you, because honestly, we've all been left to feed off each other because we've been starved of facts by MNKD & SNY, and fed a bunch of unchallenged BS from the bad guys.
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Post by hankscorpio7 on Dec 1, 2015 21:22:34 GMT -5
Amusing how short sellers have moved from Sanofi ending the partnership to EU approval is meaningless. Soon January will be upon us and no news from Sanofi will end short sellers last supposition of ending the partnership Yeah those short sellers. Ohh, I am a short seller. Cut me real deep Shrek.. I wish I was a short seller, but I did well enough being long I won't get greedy. More amusing will be reading your thoughts on script numbers with EU approval with none of the things I posted that I considered more important. If your superior engineering mathematical skills could be so kind to show us your work. Unless SNY has been doing other studies on less forthcoming continents- perhaps what Matt was eluding to- proving superiority for EMA will be unlikely. The EU also does not pay like US for drugs. Profits/ margins will be difficult. When I put all this in my brain, I don't see much reason to spend time on EU when US is the key. We need profits to build and stay afloat. But they rushed into filing for EU anyway- oh wait, they didn't. I guess there are some other non-short selling brains that work like mine.
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Post by mssciguy on Dec 1, 2015 21:31:59 GMT -5
Amusing how short sellers have moved from Sanofi ending the partnership to EU approval is meaningless. Soon January will be upon us and no news from Sanofi will end short sellers last supposition of ending the partnership That was Goldman Sachs playing the piper to the hedge funds. GS advises the hedge funds, then pursues their own diabolical strategies. It's like a breath of fresh air when one of their employees comes out as a whistleblower but even then all we get is a tip of the iceberg. How many companies have been totally destroyed for profit by these guys? If not for Al, MNKD might have been on the auction block by now, seriously. I've invested in a couple companies destroyed by shorts/HFs, one was a lithium battery company (MIT spin off) -- ended up in Chinese hands, a penny on the dollar. Same thing happened with Fisker, and electric car company, also ended up in Chinese hands. With corporate citizens like HFs, who needs enemies?
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Post by EveningOfTheDay on Dec 1, 2015 23:07:34 GMT -5
Different in it could be faster than 2 months? I love the optimism.
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