are you considering the starting A1c for ETRM at 7.6% as well as 3 year sustained a1c drop with modification to medications?
not my quote...from Dr. Shikora, Harvard MD
Given starting A1c at 7.6% and 3 year goal of 7.0% without increasing diabetic medications beats the literature on most diabetic drugs currently in market today. NOW add in that great BP reduction sustained, weight remains down and safety is good...summarizing the Harvard MD in the PR.
Good news all around...imo
The employees have received most all of these shares for free or at discounted option prices throughout their stay at the company. Ask yourself this: If you were an Apple employee and were granted 150, 200, 500 shares from management over several years and your salary is $50-60K annual. Why would you spend $10k of dollars buying 30,40,50 more shares? Wouldn't you also sell some for profit taking (not all but some)?
insider selling is overblown imo
I too have followed the collaboration of the "artificial pancreas" that is being studied. However it is a bit far fetched to believe that pumpers will still have to bolus (some) and also inhale each time they eat...it's a feasible "dual-wave" approach which is what Afrezza will be used exclusively in clinical practice but not practical in that pump screnario...it will evolve though :)
see last post to this question OPC. I suggest label not necessarily needing changed, at least not immediately. Last paragraph about SNY protocols I meant
I will also point out re: " it will take a year or more to complete trials and then we are back in the FDA queue and who knows how much additional time that will take. "
Many diabetes drugs have their utility and usage "upgraded" often with additional clinical trials completed in as little as 4-6 months and published shortly after. This data will grow rapidly and change provider usage even without an FDA "blessing", although a label update is GOLDEN!
Meanwhile the drug is going to market in the SNY bags and sales will begin while we wait for said potential driving news. It is not as if we received another CRL. I expected your otherwise curmudgeon tone to change, some at least, after the FDA approval and partner.
As I see it, you either want AFrezza to fail for your own personal gains, which is fair. OR you now can become more positive about the coming 6-12 months and beyond, also to your personal gain......continued negativity seems to only reflect a PPS and not the fundamental improvements over the last 4 months.
Agreed about the last paragraph, simple using protocols with CGM data will reveal what we all want or don't want to see. SNY is pretty clevans, I mean clever! I feel much better with them at the helm now.
It's well known that you are not in favor of MNKD mgmt. However you do not propose progressive measures forward for Afrezza utilization and/or the TS platform. OPC, do you believe that once SNY gets their protocols driving the Post-marketing AFrezza trials that the "faults" of previous Afrezza mgmt. will be washed away? Short of having the FDA "relabel" Afrezza, I believe that this is the best case scenario to be able to see the "true" kinetics and efficacy through dosing protocols suited to this insulin....have SNY redo it!
Perhaps...BUT FDA wants another PK/PD study done, so.....guess what that "might" mean?!
same story with MNKD here as I assume you are eluding to. Just that MNKD is a much BIGGER tree to shake with MUCH larger numbers of retailers owning it. It is a very HEAVY tree shaking, kinda makes me excited!!
The injection site tolerability is still a factor overall, but now less important compared to a potentially superior Ultra-concentrated insulin that can be used ultra-rapidly!! So we are led to believe from the early phase 2 results...yep worth a BITE!
sorry to bump my post, just wanted to know if anyone think this?
looks like millions in potential exercised shares will be wiped out after friday if price under $7.00?
I am not an expert here....but I am betting those are retail calls? LOL
It's not THAT great IMO. I do not see the Prandial market growing that much from Afrezza availabilitly. This notion of using Prandial insulin before Basal insulin is not only brazzen but not clinically supported in the majority of Diabetes literature and AACE/ADA guidlines. Also many MDs will be hesitant to Rx this large volume of diabetics Afrezza so soon on the market. Even Endos have to go purchase the little PFT/FEV1 spirometer now before prescribing Afrezza. Not to say they won't, but still a little hurdle. Glp-1s will still garnish alot of heavy lifting, since they are now coming out Q weekly (3 drugs now) and offer weight loss which is counter to any insulins.
NOW for the balanced part!! Afrezza is so MUCH better than EXubera and sale will be so MUCH better than Exubera. To what extent I cannot predict...yet. But I guarantee you any change in the prandial paradigm treatment will not take place for many years. BTW I believe ALL Type 1 patients should be on Afrezza unless they have pulmonary disease...THERE's a bone for ya!
I read in 10Q that Sanofi has right of first "negotiation" for acquisition ( I think that was for MNKD but maybe only for Afrezza). Yeh, so really my point being that shorters cannot justify this LOW a Market Cap based on any of the deals presented above, even the 35/65. They (shorts) know very well this is going in their favor due to HUGE positions from WS funds. But no one will dare to come clean on the TRUTH as to why....I refuse the logic of the dilution, balance sheets, poor deal, no sales...
again with the "market didn't like it" reasoning...sigh. C/mon your savvy enough to know that 72million shares are shorted, of COURSE the market doesn't like it.