JohnnyirishXM

Daily Stock Threads Feb-March 2014

150 posts in this topic

Im not usually in the habit of sending you boys to seeking alpo  but eismans what the fda says about afreeza! If you go to peterys response , i found it informative and accurate and worth the read ! Now don't kill the messenger

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Im not usually in the habit of sending you boys to seeking alpo  but eismans what the fda says about afreeza! If you go to peterys response , i found it informative and accurate and worth the read ! Now don't kill the messenger

A good George Rho response too. Sentiment seems to be changing after the Street articles and then everyone copying them with the catch phrases of lung cancer and FDA reviewer says something negative.

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I think peterys response is what the mnkd boys will be explaining at ad com and everyone has probably already been through most of this as exhubra has already been approved and was less effective! The lung cancer is a non event in my mind! I can go into great  detail about people that smoke cigarettes to smoking cocaine and on and on . I know several people friends included who have spent most of their lives on pot and cocaine and NOT ONE has a lung problem . and never has had . they have all kinds of other problems go figure hahahahahahahah my mom and dad smoked cigs for 50 years mom still goin after half her lung was cut out 08 dad  is dead but he smoked way past the point of no return! The doctors gave him pain meds so he could keep smokin hahahahahhahahahh nice right!

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I thought turgays comment was worth a read too! It goes to show how stupid the panel on the FDA really are ! They really do NOT know the questions that are important which is why they need the adcom! I guess to give the FDA some slack it would be tough to know about every disease and consequence from every drug! they would be hard pressed to know them all !Maybe is why we need adcoms ! Bring in the experts and answer the questions so they have a more informed opinion ! I think this gets approved NO PROBLEM !!!!!!!!!!!!!!!!

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This guy sounds alot like Johhny: Cool, calm and collected................ :-P

Read, think about, report. No knee jerks allowed.

 

>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>

 

George Rho

, contributor

Comments (440)

 
George Rho
I worked in New York's financial sector for almost exactly 20 years, mostly as a healthcare analyst (drugs, biotech, and medical devices), but also as an assistant research director, portfolio manager, and options strategist. My last formal job had me in charge of Value Line's premium priced... More
 
 
 
 
"Quoting an anonymous e-mailer who wasn’t happy that I wasn’t out defending his equity position in MNKD, “what gives?”

 

The simple answer is fatigue. A more substantive response is the sense that it’s all been said before and probably to no avail.

 

Both MannKind’s and the FDA’s briefing documents (BD) are long and detailed, taking most of last night to review; not sure it was the best way to spend a Friday night. The FDA’s version certainly graphically details Afrezza’s shortcomings. Indeed, as highlighted in the first draft question, the regulators point out the Afrezza provides “numerically and statistically less Hba1c reduction than a comparator subcutaneous insulin.” Moreover, it’s pointed out that the inhaled insulin didn’t meet the primary efficacy endpoint of not being inferior under the worst-case sensitivity analysis, when dropouts are taken into consideration. MNKD investors were undoubtedly also unnerved by the pages upon pages detailing possible connections between inhaled insulins and lung cancer, skin cancer, heart disease, retinal detachment, pulmonary issues and every other possible health problems under the sun. And, to the delight, I’m sure, of many of MannKind’s detractors, the briefing document also talks about “missing data,” even if not in the same context that they’ve used all these many months. Just for the record, the “missing data” the regulators are referring to is the data that wasn’t collected because some of the participants decided to drop out of the trial.

 

All that said was there anything new of significance in the 217 page MannKind BD or the 249 page FDA BD? I certainly didn’t read every single word or scrutinize every graph and table in the two documents, but my assessment would have to be no. Afrezza is not the perfect drug, I think we’ve all known that for years. Is it appropriate for use by every diabetic? Obviously not and again, this is no secret. Did the regulators have problems with the drug and certain aspects of the clinical trials? Of course, and that partly explains the reason for the AdCom on Tuesday. The FDA BD doesn’t address the following in any meaningful way, but another consideration for the AdCom panel members are the alternatives to Afrezza. Are the injectable insulins perfect? Is the reduction of Hba1c the end all and be all of treating diabetes? Are diabetics who need insulin likely to begin therapy earlier if they have the option of inhaled insulin or not? Insulin Aspart may result in slightly greater Hba1c reduction than Afrezza, but how important is that when some diabetics postpone treatment, sometimes for years, because of an aversion to injections? A Seeking Alpha article on Thursday reviewed in detail the many shortcomings of subcutaneous insulin. None of this was discussed in the regulators BD, but all of that is clearly of relevance in the final analysis.

 

Bottom line, Afrezza met the primary endpoints in the trials for both type 1 and type 2 diabetes, as set by the FDA, and none of the details that are spelled out excruciatingly in the BD are sufficient to derail approval, in my opinion. Significantly, too, even the most critical assessments by regulators show very little evidence of concerns about the drug’s safety.

 

As to MNKD stock’s price action yesterday, where to begin? We’ve talked about fear, fiction, misinformation, and disinformation in previous articles. I think all of this was on display yesterday. Articles emanating from anonymous authors on websites like Seeking Alpha and Motley Fool can affect a stock price, or so we’d like to believe. So, imagine the impact of major news outlets like Bloomberg, Reuters, Fox Business, theflyonthewall, and others, all of which heralded their stories early yesterday morning with titles that were clearly alarming and disconcerting. As if often the case, however, and I’m sure many long-time followers of MannKind will agree, none of the authors of those stories provided any context or perspective. Indeed, the rapidity with which the articles appeared strongly suggests that the writers might have gleaned the draft questions, did a brief google search, and rushed to publish…. report first and ask questions later.

 

MannKind investors, a group that appears to include many that follow every painful tick of the stock price, clearly didn’t fare well last week. That said, the company lost $156 million in market value yesterday, contrary to the billion-dollar figure some regular commenters on these pages keep on repeating. That’s not all, it’s also worth keeping in mind that the stock market in general, and individual stock prices, in particular, do not always accurately discount news, especially in the short term and factoring in an age when “news” can be so easily distorted."

 

29 Mar, 09:34 AM
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Im always the cospiracy theorist but the reason there were so many patents to this thing and they are expensive as well , like 2000 a copy renewed every year! and thats what i know in other fields so my point is they dont want any other BP to get their ideas or even close to them! This gets approved anyone coming close to this will be sued heavily ! i think the technology of technosphere is ground breaking! You might want to remember how Howard hughes dad stole the idea for a drill bit from drillers in a bar in louisiana got a patent and then sued the same drillers for using the drill bit they created! So i think mnkd must  realize they have a big gun here. 

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I also think if i was in the bp field and i could not get a patent  on a new drug that was gonna get approved eventually even if the deck was stacked  ! I would have to buy the stock to get the benefit out of the drug so you may see some buyers on board knowing its there only chance to make money on this drug because of the patents that mnkd controls! conspiracy theory # 57 TY johnny hahhahahah from domestic

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MNKD is doing something similar to what CHTP did before approval.  Check this chart out.  It was beaten down the week before kinda like MNKD was, went below 2.50 on Jan.13th, then after approval it took off and gapped up, and now it's over twice the price it was before approval, over 5 bucks, so something to look forward to maybe.

 

post-3688-0-74044300-1396223633_thumb.jpg

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Does the link take you directly to the show?

I am not hearing anything. 8:09

 

Got it....but unable to post in chat. :x

 

When is the actual AdCom vote ?

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Does the link take you directly to the show?

I am not hearing anything. 8:09

 

Got it....but unable to post in chat. :x

 

When is the actual AdCom vote ?

About 4:30pm on tuesday April 1st at end of adcom discusion..

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trading will be halted on april 1st all day,,no trading til about 5-5;30pm in ah,after decision votes..

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At the very end of the show tonight you said something in regards to the company being worth $5.00 I didn't catch the context. Care to repeat?  Thanks. I did hear the wild swing possibilities.

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At the very end of the show tonight you said something in regards to the company being worth $5.00 I didn't catch the context. Care to repeat?  Thanks. I did hear the wild swing possibilities.

I meant depending on how the votes go and why if disapproved they had chance to get approved again and patents on delivery device,,,it was worth 5 bucks..all depends on what happens to approval,,conditions..imo

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Okay. Thanks. I knew I missed something. I think the tecnosphere delivery system is great for us in any case.

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I'm going to only argue with you boys on the type one approval ! I say it gets approved also but most probably don't understand the reasons for the higher A 1c  results and thats why i sent you to turgays response on seeking alopo ! They imo will get type 1 as well as the scientists explain what has to happen! The pulmonary problem will get a label for copd and  asthma just like exhubra ! And there will be a Label for children just like my kids doctor said they will never prescribe that for children with growing lungs  without plenty of trial data!!!!!!!

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Just got more at 4.08, lol ya I'm a glutton for punishment! ahahaha  Go MNKD!!!

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I saw Michael Lewis interviewed on "60 Minutes" last night.  Part of the story was about a couple of guys who started their own Exchange( IEX ). If I understood it correctly, they built a system that can tell when an HFT program is being used, and when it finds an order coming through on their system, it sends it to a "Magic Shoe Box" that they have on site. The magic box then sends the order back out through another 60 kilometers of fiber optic (rolled up in a coil) that slows down the order enough so that it doesn't hit first.

 

http://www.youtube.com/watch?v=BweADB78tBY

 

If link doesn't work, search Michael Lewis "60 Minutes" on youtube.

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The fox in charge of the henhouse cmon fog horrn legg horn 

everyone still packin their balls after today hahahahahahahahahhahahahah

 

Yup! Inhaled another small breath at 4.05

 

If worse case presents itself, lowered my average for the future.

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Yup! Inhaled another small breath at 4.05

 

If worse case presents itself, lowered my average for the future.

 

Glad to see someone had balls besides me, or lack of sense lol  We will see soon enough!  Averaged in at 5.22 now with waaay to many shares. Overweight to say the least.  Dropped my average down by .60 cents today though on that scare.

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Glad to see someone had balls besides me, or lack of sense lol  We will see soon enough!  Averaged in at 5.22 now with waaay to many shares. Overweight to say the least.  Dropped my average down by .60 cents today though on that scare

Ummmmm................Ill go with lack of sense. Lol!

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