|
Post by esstan2001 on Mar 4, 2015 10:04:38 GMT -5
inhalation direct from a blister pak without the inhaler the FDA required to pass device clearance? certainly not a very controlled combination of air swirl-mixed with Technosphere- insulin. I can imagine clumps of drug powder arriving up the nostril, inducing a cough.
Certainly NOT a fair question when not being used as directed.
|
|
|
Post by esstan2001 on Mar 4, 2015 9:38:33 GMT -5
preliminarily qualified-
they dry-ran, tested, and obtained satisfactory data per GMP / FDA guidelines in advance of having the FDA 'folks' show up and do it for real.
|
|
|
Post by esstan2001 on Mar 3, 2015 9:30:30 GMT -5
|
|
|
Post by esstan2001 on Mar 3, 2015 9:19:45 GMT -5
looks like 1st 4 weeks of sales for the sanofi soft launch, and expectations for pricing pressures are the basis of the downgrade... plus look who happily presents this tripe AND misrepresents and intended 'soft launch'. Also a lame graph to accentuate the word of mouth uptake MannKind Rating, Price Target Are Cut by Goldman on Slow Afrezza Launch By Adam Feuerstein Follow | 03/03/15 - 08:16 AM EST Find out if (MNKD) is in Cramer's Portfolio. 0 NEW YORK (TheStreet) -- MannKind (MNKD) was downgraded to a "sell" rating from "neutral" by Goldman Sachs on Tuesday, with the analyst citing the slow commercial launch of the inhaled insulin Afrezza coupled with growing downward pricing pressure for all diabetes products. Goldman cut its price target on MannKind to $3 a share from $6. MannKind shares were down 8% to $6.10 in premarket trading on Tuesday. "Diabetes market dynamics have deteriorated as reflected by growing pressure on prices and slow launch uptakes -- both of which have been unfavorably influenced by payors as they leverage their formularies," wrote Goldman analyst Jay Olson in Tuesday's research note. The downward pricing pressure exacted by insurers is likely to force Sanofi (SNY - Get Report), which is seling Afrezza in the U.S. under a partnership with MannKind, to offer discounts up to 40% off the product's list price -- double what Goldman originally expected, Olson wrote. The commercial launch of Afrezza -- about one month old -- "has also fallen short of our expectations," according to Olson. Goldman slashed its 2025 sales forecast for Afrezza to $1 billion from $2 billion. On Monday, Afrezza was give a lackluster review -- "modestly effective" -- from The Medical Letter, an independent, non-profit organization which evaluates prescription drugs. Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.
|
|
|
Post by esstan2001 on Mar 2, 2015 9:11:01 GMT -5
If you search on the Mar 2 issue of the Medical Letter, the link to the Afrezza article requires subscriber login, but there is an option for a free trial where you have to list your personal info and medical specialty... any docs want to try, and see what they really say if you get both sides of the story?
|
|
|
Post by esstan2001 on Mar 2, 2015 8:40:11 GMT -5
Hi Baba, Your share vote is prorated to what you own, so I would pull back the entire position to get a fair and proper weighting. There is a date by which they invite us to the meeting as shareholders of record. True, 1 share will entitle you to the invitation, but I want to bring all my representative guns to bear when I be there on dat day. Oh well, was hopeful you would save me from researching that particular date (but not from being lazy :-) )
|
|
|
Post by esstan2001 on Mar 1, 2015 18:56:56 GMT -5
iamtoseek posted the relevant link for fidelity. all your answers are there. Another point I posted a few days ago about the program- you loose voting rights to your shares as long as they are on loan. I for one do not want some short or hedgie gaining any leverage on us longs so... No problemo, as all you need to do is 3-5 days before the date of ownership to vote, you recall them from the program. Vote your shares, then should conditions warrant, you can decide to place them back on loan. BTW, that leads me to my question- I assume one must 'possess' their shares on the day of the annual meeting; however it may be some time before that you need to have them listed as in your control (they stay in street name but you are legal proxy if I have my terms correct- maybe a lawyer like baba can chime in :-) ) So, anyone know what that date is? (ok, maybe I am being lazy)
|
|
|
Post by esstan2001 on Mar 1, 2015 18:39:33 GMT -5
didnt even answer your Q- cash or margin wont matter once you agree to loan; my account is my retirement IRA and Roth. As for minimum, I did not notice anything but recall reading someone mention something about 100 or 250k but not sure if that was in reference to TD or Fid.
|
|
|
Post by esstan2001 on Mar 1, 2015 18:37:05 GMT -5
call them, tell them you want to make available your mnkd position to loan out. they will send you about 5 pdf's of disclaimers etc, but one of them is called a Master Services Lending Agreement which you can sign and fax / scan and email back. Your shares will then be at Wells / BoA and you will collect the prevailing interest, annualized around 20% right now, and it will mark to your account monthly. I expect the rate to be fairly variable, as will the value of the lend position, but it's an idea that I think allows one to recapture some of the lost value while we wait. I was pretty conflicted about doing this, normally holding all in cash accounts so the shares are not loanable, but I guess I passed a bit over into the dark side.
|
|
|
Post by esstan2001 on Mar 1, 2015 9:57:46 GMT -5
can't wait for SNY to address this with improved label and marketing that focuses on real time control, not AIC numbers.
|
|
|
Post by esstan2001 on Mar 1, 2015 9:56:26 GMT -5
Reading the comments section in the ukmi link, , it is no wonder people have so many misconceptions regarding afrezza.
|
|
|
Post by esstan2001 on Feb 26, 2015 10:51:24 GMT -5
What is also interesting is that we haven't seen a patient who has said "I tried it and it sucks"
-that is one of the key points I came away with after trying to read every patient blog and social media outlet I could find.
|
|
|
Post by esstan2001 on Feb 25, 2015 22:07:31 GMT -5
scary :-0
|
|
|
Post by esstan2001 on Feb 25, 2015 22:03:30 GMT -5
when I reread all the Sam, Mike, Elizabeth, Adam, et al twitter testimonials, it is hard to come to any conclusion other than Mann is correct on all counts. Toujeo may get the sales push, but Afrezza will get the patient pull. Like one of the Cafe Pharma reps said, it will be nice to actually have a drug that will sell itself.
|
|
|
Post by esstan2001 on Feb 25, 2015 21:09:47 GMT -5
Doesn't this seem ahead of expectation? How did they pull that off if I am not wrong...
|
|