People here who do not understand what FDA wanted to know from Affinity 1 stand to loose here due to this panic cell created every day by picking different aspect of trail results..
All FDA wanted to know is if Dreamboat creates any lung function issue. The aeration of powder and the quality of powder + air mixture that is delivered to mouth depends on the device design equally as it depends on the powder technology (technosphere). I stand by FDA's CRL when they want MNKD to run P III with the device they plan to launch the product with.
So MNKD conducted PIII study and ONE of THE primary endpoint was to compare FEV1 performance between Afrezza with Medtone vs. Afrezza with Dreamboat. Mankind DID RELEASE the numbers on FEV1 comparing both the devices. FEV1 difference was 0.01 L which is insignificant.
The comparison from FDA perspective ends right there. The safety profile of dreamboat is same as medtone.
Now separately, dreamboat is proving non-infiriorty compared to injectable insulin in the same affinity 1 study with other arm. Now, even if medtone performed better in reducing A1C compared to dreamboat .. IT JUST DOESN'T matter.....
its none of FDA's business if MNKD wants to launch with Dreamboat even if it performed less than medtone in reducing A1C level AS LONG AS..... dreamboat is 1) as safe as medtone (FEV1 data released as mentioned above) 2) As effective as injectable insulin in reducing A1C level (which it is as per the data of Affinity 1 comparing A1C level with third arm of the study)
Bottomline, FDA will approve dreamboat irrespective of medtone's better performance on A1C reduction as long as FEV1 values are same. WHICH IT IS... SO people, have patience.. don't get manipulated... hold on to your stocks...
Phase 3 data from studies 171 and 175 that met the primary efficacy endpoints of these studies and did not show any adverse safety issue that would reasonably be expected to prevent approval of AFREZZA. So many had sold.. This was the real reason I bought back in on the 14th, August. But the pps straight up got manipulated and retailers panicked..
Thanks for the discussion of the separation of issues. I've been long but am somewhat skeptical of the inhaler safety equivalence;. The rate of cough for Gen 2 is higher as is the rate of discontinuation due to cough. Is there a well established criteria or precedent that this is sufficient for the FDA to establish equivalence?
Wild B, any time you inhale something that is anything more than air itself (unless in L.A.) you will have a cough at first until you get used to it. That is a normal body function. Many drugs produce a cough, even pills. Example is a blood pressure medical on the market (a good one at that too).
Remember even water and O2 has a side effect. Afrezza is equal to or better in many areas of DM treatment. Is it for everyone, no. Nothing is on this world we live in. Any time a patient can inhale medication Vs over a thousand injections in to the body in a year (picture that in your mind), and control the BG level faster and more efficiently with less downside of shock, you have a viable product that can help those with DM I&II. So ask yourself is this a good product to treat DM and those that have it?
Remember Insulin isn't the answer for all DM patients either. But it does help, along with diet and exercise. There is not just one thing. Now there are more options the just pill, injection and diet and exercise. Think about it, more options to a better life style and health. I for one wouldn't wish DM on anyone, nor would I stand in the way for them to have options on treatments. What about you?
Yes, drop out are considered individual preference. Remember different people will react differently to different type of drug. FDA will look at the fact that number of patients required to statistically establish safety and efficacy DID COMPLETE the entire trail and without issues. As mentioned in the release, cough is more at the start (thats the minor side effect of ANY DRY POWDER inhalers including block buster ADVAIR used for asthma).
Bottom line is those patients who decided to continue did complete studies without issues and cough does go away eventually after 24 week period. So no issues related to cough as well.
And one more thing... Adverse events is different and drop out is different. Since withdrawing consent is enough to dropout without giving reason, FDA doesn't punish the company on the grounds of pure suspicion that Oh, drop out must be an adverse event.... FDA does understand that different people will have different tolerance when it comes to tolerating initial minor side effects while going on to new therapy. If they choose to discontinue .. its their personal choice... as long as they didn't report something like severe suffocation or breathing difficulty... (and no one prevents patient from reporting that event to physician after all).
I want more people to read this and hence will keep posting this line to keep it on top of the list.... This is not pumping piece but my opinion based on having spent last three years of my consulting work on inhaler device space...
No need to keep any message anywhere. Messages on message boards don 't hold up stock prices. They only create short term ripples that only matter to day traders and short term gamblers. Diabetics who use insulin understand the significance of the results of the study just released. AFREZZA is highly likely to hit the market and as news of this spreads and doctors tell their patients and offer it as an alternative to needles and offering the better control it seems it has they will buy the drug. The earnings will follow and the stock price will inevitably climb sky high. Diabetics dont care what some stupid short posts on a message board. This drug will be a game changer for millions of diabetics all over the world and their quality of life will improve. I wear an insulin pump that Al invented and later sold to Medtronic. He does good work. I know what this will mean. It doesn't mean every single diabetic everywhere will use Afrezza but as everyone knows the market is so vastlty huge only a portion of it will still mean numbers too big for me to estimate accurately. Would not surprise me one bit that over the next several years this stock becomes a ten bagger if it doesn't get bought out first. The shorts are like a guy standing on the train tracks about to get run over by a speeding freight train yelling at you about how the mortor is faulty or the fuel doesn't make the engine run or what old technology trains are or whatever head in the sand reason he can think of just before he gets plowed over and splattered like a Galager watermelon. Longs chill out and relax. Dont bet the house or anything foolish but give it time and patience will be handsomely rewarded ...just my opinion.
Sentiment: Strong Buy