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Post by babaoriley on Jan 10, 2014 14:49:42 GMT -5
The Top Ten things overheard at a Valencia watering hole on Friday:
10. Well, how convenient, a surprise topic for the JP Morgan conference. 9. I knew it, as soon as that Baba guy on that board of buffoons started becoming optimistic, it would be the end. 8. Did you get all your selling done yesterday? 7. I thought we had a tap on Martin Shkreli’s phone and email. 6. Will this become known in MannKind lore as the April Fool’s Advisory Committee or the April Fools’ Advisory Committee? (subtle) 5. This is actually good news, I mean, it gives the speculators yet another chance for a 180 degree swing! 4. I don’t understand why the hedge fund manager was so upset with me this morning, I told him earlier in the week we were preparing an important NR for Friday morning release. 3. No one tell Al about this, not a word; let it be a surprise for later! 2. Who is Dewey, Cheatham & Howe, LLP, and why are they saying these things about us?
And the number one thing heard at the Valencia watering hole:
1. Friggin FDA
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Top Ten
Jan 10, 2014 16:12:37 GMT -5
Post by rak5555 on Jan 10, 2014 16:12:37 GMT -5
And how delightfully deceitful for the FDA not to include the adcom request in the 74 day letter. Talk about a head fake.
After a million page NDA filing, supported by thousands of patients and multiple trials over 10 years, what kind of questions and answers could possibly be discussed on April 1st that would influence a decision on April 15th? Could it be that they are inclined to approve Afrezza, but due to the notoriety this drug is likely to garner, they want one last review by a panel so that no one can question whether they were abundantly cautious if anything goes wrong in the future?
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Top Ten
Jan 10, 2014 16:22:26 GMT -5
Post by babaoriley on Jan 10, 2014 16:22:26 GMT -5
I hope the latter is the explanation, rak. But this was an opportunity for some shorts to cover. Really, who knows, but I guess we may as well go forward with the belief that it's all on the up and up.
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Post by notamnkdmillionaire on Jan 11, 2014 8:55:38 GMT -5
And how delightfully deceitful for the FDA not to include the adcom request in the 74 day letter. Talk about a head fake. After a million page NDA filing, supported by thousands of patients and multiple trials over 10 years, what kind of questions and answers could possibly be discussed on April 1st that would influence a decision on April 15th? Could it be that they are inclined to approve Afrezza, but due to the notoriety this drug is likely to garner, they want one last review by a panel so that no one can question whether they were abundantly cautious if anything goes wrong in the future? Maybe an apology to the company for dicking it around for so long and costing it untold millions of dollars and the continued suffering of millions of diabetics around the world. The FDA kills more people with their inaction than they help.
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