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Post by stevil on Dec 3, 2015 16:08:46 GMT -5
Not sure what prompted the last part of your message, but I consider you one of the "good guys". I'm not here to choose sides. I could flip long any second as long as good data comes out to support the change. You have an opinion and you usually give thorough explanations and research to support it. I just happen to take the other side most of the time. Doesn't make you my enemy. We're just different members of the group of blind men feeling an elephant It is sad when people make things personal...
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Post by stevil on Dec 3, 2015 15:57:37 GMT -5
Some more rabid "speculation" which is another word I hate now - almost as much as "hope"! The long term patient lung safety studies were baked in to the Sanofi-Mannkind partnership and might be considered an instrumental part in the future strategic planning for Afrezza. Sanofi knew it would have responsibility for the 5 yr, 8000+ patient lung safety studies (the most daunting PMR from the FDA) when it partnered with Mannkind. www.accessdata.fda.gov/scripts/cder/pmc/index.cfmThe first 2 Afrezza PMR studies (of 4) are complete and Sanofi is recruiting for the 3rd PMR (pediatric safety study). In addition to the results from the strictly controlled euglycemic clamp and PK/PD clinical studies, they need to understand absolute and temporal dosing requirements in real life use. They need to glean as much information as possible to understand the barriers to Rx. The best strategic minds had BETTER be at work in Sanofi's Clinical & Regulatory departments. I have to assume that Sanofi's Marketing, Clinical/Regulatory groups are: 1) following the experiences of more public early Afrezza adopters and Afrezza users in general, and MEETING with them in person to discuss. 2) laying out clinical protocol approaches to satisfy the lung safety PMR and incorporate the collection of 1-2 year superiority data on Afrezza. 3) holding advisory board meetings with opinion leader MD's, PhD researchers, and other experts to present early adopter results and to get feedback for the lung safety clinical trial protocols and other smaller cohort studies. It sure seems to me that Sanofi is not giving up on Afrezza. Fully agree with you regarding what I would expect Sanofi to be doing. Finally with this advisory board meeting we are perhaps getting some evidence that this can be moved from the realm of speculation and hope into the realm of a realistic expectation. I had expected it to occur sooner, but certainly willing to give the benefit of the doubt that they know better than I about how to accomplish what needs to be done. I will dump what little remains of my cashback rewards on my credit cards into my fidelity account and scrape as much money as I can to put into MNKD if SNY affirms a strong commitment to them. SNY will dump obscene money into making sure Afrezza is successful if they choose to stick with it. SNY needs something big right now, and while I don't think they're quite desperate, they probably aren't far off. SNY needs something big to stay a market leader.
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Post by stevil on Dec 3, 2015 15:05:11 GMT -5
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Post by stevil on Dec 3, 2015 2:06:15 GMT -5
Fidelity just lowered the rate to loan shares from 42.5% down to 35%. It's all about supply and demand. I'm kind of confused... Isn't it a bad thing that there is massive covering and the SP still hovers around $2.20?
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Post by stevil on Dec 3, 2015 1:21:08 GMT -5
This is very simplistic reasoning and does not fall in line with reality based on the fact that many commonly prescribed drugs are inhaled for many common conditions - used daily (e.g. Asthma) Asthma drugs help open the airway ( helps the lungs function) Not any where close to inhaling of other particles. It looks like others have piled on enough. Sorry to say it, but what you stated was incorrect. Just because you can't see them, doesn't mean you're not inhaling particles 100% of the time. Atmospheric air is mostly composed of nitrogen and oxygen and other trace elements, mostly particulates and other gases. You inhale dust with every breath. If you live in an urban area, there's a good chance you're inhaling the brake dust from people's brake pads. Think about how random that is... Now think about all the other things you're inhaling if you're inhaling those things... linkyI did a quick search and if you want to do research into what particles you inhale and how bad your city is, click here. Next, those asthma drugs you referenced. Look up Advair diskus inhalers. Better yet, I did it for you. Notice what it says at the bottom of the description. Inhalation POWDER. Advair is usually used for people with COPD, although it can be used for asthma too. If you think about it, you can't inhale something and get an effect from it without particles entering your lungs. Unless you live in a vacuum, you're always going to inhale something.
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Post by stevil on Dec 3, 2015 0:58:55 GMT -5
patentimages.storage.googleapis.com/WO2014012069A2/imgf000056_0001.pngIn a way, it is carbon coated, but you're right, it is WAAAAY simplified. For instance, CO (carbon monoxide), is not a safe molecule to inhale. It binds to hemoglobin in the blood and inhibits its ability to bind oxygen, essentially suffocating a person who inhales it. Hydrocarbons in gasoline eventually burn into CO2 and H2O. I'm sure many here know that we exhale CO2, but it can actually cause acidosis if we inhale too much of it back into our body. So carbon is actually not always ok to inhale. We'd actually be better off if we never inhaled it. The only time I can think that it would be beneficial to inhale carbon (other than medication of course) is during hyperventilation. You blood can actually become alkaline, so inhaling CO2 prevents alkalosis. Sorry for the science lecture. Figured I'd make use of info that feels worthless right now and share it with others. So, he's right about it being carbon coated, but incorrect about that being the reason why it's ok to inhale Afrezza.
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Post by stevil on Dec 3, 2015 0:35:56 GMT -5
get a girlfriend or equivalent. Seriously. I have a fiancee But thank you for thinking of me! Also if you can't see the humor in our situation then you are taking this investment far too seriously. Get out while you can and put your money into ETFs. I think that watching MNKD take these wild fluctuations is not for the faint of heart. Congrats on getting engaged Patryn! Should have your own thread just for that!!!
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Post by stevil on Dec 1, 2015 16:23:12 GMT -5
please explain the cash position. Most were under the assumption that dilution of the ATMs/LOC money could bring in another $68m in addition to the $60m they have with the Israeli money....they need $25m minimum in the bank at all times to operate....so we are talking about a 30+m share dilution in the near future that will leave us with $103m in operating money at an $9m burn rate...so we can survive till Dec 2016.......yet you say 2017? There is one theory which depends on stars aligning... that avail ATM shares were sold awhile a ago at a better price, not yet to be sold at potentially lower still price, and that we roll out of Q3 with exactly $25M and then can burn through all of it in Q4 because the restrictive covenant regarding having $25M cash only gets triggered at the end of a quarter. I hope that MNKD has a more conservative approach than getting down to less than $25M with a deadline that it must be replaced by end of quarter to avoid default on a loan covenant. It would also be nice if MNKD had utilized ATM to raise capital, they would announce it... but even I admit that if it did happen, I think there is little chance we'd be told about it... so who knows, that may actually have happened. A bit strange to have faith in it, lacking evidence, but it's not the strangest hope to believe in. Realistically, there would need to be a larger issue of shares to get us into 2017 unless MNKD again takes drastic measures and curtails TS pipeline development. The part that's really confusing (without speculating on a plan that fell through or SNY ramping up marketing in accordance with the removal of headwinds/barriers) is just taking Matt's comments at face value. He seemed pretty adamant that dilution would be a last-ditch effort and would not be needed. Ok, I have to speculate... The way all the events of this quarter unfolded tells me that something big either fell through or something is just on the horizon. I would hope that MNKD wasn't putting all their eggs in a mythical basket and instead had something water-tight and concrete to rest that confidence on.
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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 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 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 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 stevil on Nov 30, 2015 21:22:09 GMT -5
Does anyone know why SNY is doing all of this before they launch rather than concordantly? I honestly can't tell if this is good news ha. It would seem to be proof of their commitment, but are they doing it out of necessity or out of ambition?
Are these trials going to act as keys to open up the hypothetical floodgates or are they just trying to be productive while they bide their time, waiting for _____ to happen?
It could make sense that they're firing up the engines and waiting for a label change. Is that the overall sense of what this is about?
Or do we think that we're shifting our focus more to the Euro/Asian market and hoping to find success there while America catches up?
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Post by stevil on Nov 30, 2015 17:59:14 GMT -5
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Post by stevil on Nov 29, 2015 18:30:53 GMT -5
But what if liquidation isn't one of the cards in Al's hand and SNY knows it? That is a possibility I didn't consider I think it crazy that a man would spend his whole life accumulating wealth only to lose it all in the last 15 years of his life... But I guess he's the kind of guy who would... he's already willed the great majority of his estate to charity. I'm with you guys in my heart. I just hope more comes to light that allows my head to follow...
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