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Post by spiro on Apr 1, 2014 18:03:28 GMT -5
Thank you to all the great posters on this board for helping me keep my sanity the past several brutal weeks. I know a lot of other people must feel the same way. This board has had over 2200 viewers check in during the past 24 hours. the game is not over yet, but we can surely see the light and the end of the tunnel now.
Spiro, You know, it still might be hard to sleep again tonight, but for a different reason
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Post by spiro on Apr 1, 2014 17:54:02 GMT -5
Thanks Silentbob, believe me your input helped.
Spiro
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Post by spiro on Mar 31, 2014 14:25:04 GMT -5
thanks for the kind words Stevieray, but I assure you that I am not on the AdCom. My knees are just as wobbly as yours.
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Post by spiro on Mar 31, 2014 10:04:43 GMT -5
Thanks for cheering me up Baba, DOA, good grief, what a thought. My irrational exuberance meter is down to zero. I am still remaining positive that something will be approved by the AdCom, but unsure of the potential label recommendations.
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Post by spiro on Mar 30, 2014 12:34:54 GMT -5
mnkdfan, Thanks for the interesting post, my confidence is starting to creep back. I am in the middle of a page by page analysis of the BD with a fellow investor. We are at page 80 and so far, I only have a few concerns, mostly about the PK and PD issue. I am not sure about how MNKD will address this issue and if it could be a reason for rejection. The FDA's reviewer's irrational verbosity makes the BD difficult to interpret.
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Post by spiro on Mar 29, 2014 11:00:08 GMT -5
Damn Rak, now everybody knows that I am a whiner. Actually I have not lost faith in Afrezza and Technosphere. But I must admit the BD has eliminated most of my irrational exuberance. It's obvious now, that Ashiwi is the most optimistic poster. I still believe that the only thing that can prevent FDA approval of Afrezza is FDA politics. That is what bothers me the most in the BD. Other posters have pointed out the editorializing of the FDA concerns. I am no longer madly in love with MNKD. Let's say, I am now down to having a big crush on MNKD. Babaoriley's wisdom has influenced my emerging caution.
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Post by spiro on Mar 28, 2014 19:32:16 GMT -5
Liane, I am still around, just trying to digest today's events like a lot of other investors. I did weaken today and sell 25% of my share control. I truly believe that the MNKD team was expecting most of the FDA's response and I am fairly confident that they will be able to address the FDA questions with adequate answers. Since when does the FDA not approve drugs unless they can be effective with 100% of the patients. That's why they have endpoints. I think the FDA's missing data argument is weak at best. Numerous drugs are approved after having high dropout rates because they met their endpoints. I do have concerns about the dosing in type 1, but the FDA has let Afrezza advance to this stage without too much concern here. What happened to the concern about the withheld data from the 3rd arm? The FDA questions remind me of questions that would be asked in phase 1 trials. We are not going to see that light at the end of the tunnel until the FDA approves something. I think Jeff Eiseman has the best grip on this thing, actually his thoughts appear to be similar to yours. seekingalpha.com/article/2115243-what-the-fda-document-says-about-afrezza-implications-for-fda-approval?isDirectRoadblock=false&uprof=Spiro here, depressed in Miami, still battling. But what do I know?
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Post by spiro on Mar 28, 2014 7:45:52 GMT -5
Up .60 on 525 k with 45 minutes until open. I guess, so far investors like what they see.
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Post by spiro on Mar 27, 2014 14:49:10 GMT -5
I could go to Miami Beach, but I am such an awful sight in swim trunks, the authorities wouldn't let me get near the beach.
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Post by spiro on Mar 27, 2014 12:28:54 GMT -5
That's exactly why we should all be hiding under our beds until tuesday.
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Post by spiro on Mar 26, 2014 16:59:26 GMT -5
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Post by spiro on Mar 26, 2014 15:26:45 GMT -5
Make no mistake about it, owning MNKD is no picnic. Evidently, I am an investment coward, because I kept away from my computer all day. The expression no pain, no gain is perfect for MNKD longs. They say, One must be willing to endure some inconvenience or discomfort in order to achieve worthwhile goals. Wow, is that ever true, the shorts are a royal pain in the ass. So here we go again, the main event is tuesday. All the facts and evidence, overwhelming support FDA approval with a strong label, but somehow the shorts are temporarily winning the price battle. All I can say is, let them go for it. I refuse to sell one share at these prices. I am fully prepared to go down with the ship, I just hope it's not burning and become a rocket ship to hell. I am working on a contingency plan. i am going to barricade myself in the den next tuesday. I will need to pile sand bags up to the ceiling. This should keep me safe from my wife for a while, if things go array.
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Post by spiro on Mar 25, 2014 18:53:50 GMT -5
So how many members will sit on the AdCom?
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Post by spiro on Mar 24, 2014 22:33:35 GMT -5
Give the guy a break, he probably has MNKD article writer fatigue. This process seems to be wearing everybody out but the shorts. After the AdCom votes overwhelming to approve Afrezza on Tuesday, it will be all over for the little short boogeymen. They know it's coming, but they just don't know how to quit. I guarandamntee you the shorts are not happy with MNKD's share price sitting at $5.91, particularly with the Biotech's getting slaughtered recently.
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Post by spiro on Mar 24, 2014 11:50:23 GMT -5
From Wall Street journal blogs.wsj.com/moneybeat/2014/03/24/investor-concern-mounts-as-biotech-stocks-continue-slide/11:07 am Mar 24, 2014 MARKETS Investor Concern Mounts as Biotech Stocks Continue Slide ARTICLE By MATT JARZEMSKY Looks like Friday’s weakness in biotechnology stocks was more than a 24-hour bug. The sector is taking another hit today, leaving traders and analysts wondering whether these stocks’ rally the past year has fund managers looking to take profits off the table. Bloomberg Biogen Idec Inc.BIIB -3.23% slumped alongside Gilead Sciences Inc.GILD -0.29% and Celgene Corp.CELG -2.08% Monday morning, underperforming the broader market. The iShares Nasdaq BiotechnologyIBB -3.35% exchange-traded fund, which tracks the sector, slid and the biotech-heavy Nasdaq Composite Index underperformed other broad market benchmarks. As of late Monday morning, the two-day session slide in the biotech-sector ETF amounted to 8.3%. Friday’s 4.7% drop alone marked the biggest daily decline in the ETF since August 2011. “The level of volatility is increasing and investor concern continues to go higher,” RBC Capital Markets analysts write in a research note dated March 23. “Sentiment is waning the most we’ve seen in the last [two to three] years.” Traders and analysts blamed Friday’s selling on a letter from three Democrats on the House’s Energy and Commerce Committee requesting a briefing with biotech bellwether Gilead on the high price of a new Hepatitis C drug. A bigger question is whether a herd of “generalist” investors—who buy shares across many industries, rather than focusing solely on biotech—have piled into the shares of late and are now taking profits. Market participants who follow the biotech industry say some of these investors may be less up-to-date on the science, market risks and trading dynamics of the highly specialized biotech sector. “We think the generalist money is sitting on a lot of profit and is ‘getting spooked’ because of ‘government’ starting to raise questions about drug pricing,” RBC says. For what it’s worth, the bank added it thinks the Gilead pricing concerns are just “headline noise.” The biotech-sector ETF is still up 53% the past 12 months, well ahead of the 19% advance in the S&P 500.
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