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Post by daleplatt on Aug 22, 2013 22:02:01 GMT -5
Hello to everyone.
I was wondering; do any of you read the MNKD MB? Have any of you had a chance to read my posts of late over there? If not, may I suggest you take a look at my post entitled: Paid professional posters already preparing to take over this "PUBLIC" Message Board. Then check out the specific names I mentioned who are spreading FUD all day over there. There are many more names I haven't listed; but if you read all the FUD posts today and yesterday you can find many more. Just click the names of the posters you have an idea are doing the posting.
In addition, I think the hedge funds who have shorted MNKD have been able to block anymore of my posts. I tried rebooting my cable/wireless modem, using 3 different search engines - yahoo, google, and mozilla firefox - no luck, folks. Then I typed in my Yahoo search entitled: Unable to post into yahoo finance message boards, and after I had to be more specific about all the steps I took to correct the problem, I found 4 posts from other people who had the same issue, but there was one big surprise answer I hope you take a few minutes to read who was complaining about 3 solar MB stocks that were infiltrated with unwanted posters working for hedge funds trying to manipulate those stocks. This happened after MNKD received it's 1st CRL. Read my post over there to read Savzak's replies to me.
More importantly, there is one post form this afternoon called, silentbobsilent, authored by qqueue83, whom most of you know quite well. He is very intelligent and knows tons about MNKD. If anyone would be so kind as to send a link, or better yet the post in it's entirety to this message board, I would greatly appreciate it, because I would love to hear all of your opinions about the Affinity Trials 1 and 11.
Thank you one and all.
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Post by BD on Aug 22, 2013 22:35:14 GMT -5
I'm not sure I've succeeded in rebooting my cable/wireless modem using a browser. Usually I use my finger (on the reset button/power switch). LOL.
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Post by dreggy on Aug 22, 2013 23:06:13 GMT -5
Is this the post?
Silentbob's analysis was based on MNKD's hypothesis which was proven incorrect in 171.
"One advantage of Afrezza is that it has much lower hypo risk, so you can manage your patients at a much lower A1c if the doctor chooses to do so (that will require some time)."
In trial 171, the FDA allowed MNKD to bring in an independent monitoring committee to make certain clinicians were dosing basal high enough to highlight the benefits of Afrezza's short tail. Management stated repeatedly that proper (higher) basal dosing along with Afrezza's short tail would "drive A1C's considerably lower" when compared to RAA.
The problem is it didn't happen.
Now we’ve gone from talking about superior 171 results, paradigm shifts and gold standards to talking about how the longer lifespan of red blood cells caused A1C readouts in Afrezza to be 1.9x higher than RAA in 171.
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Post by daleplatt on Aug 22, 2013 23:06:28 GMT -5
Sorry. I rebooted my computer by shutting it down and then unplugging the tower and then the wireless modem. After I got up and running again, I tried three different search engines to post on the public board...
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Post by daleplatt on Aug 22, 2013 23:11:19 GMT -5
That's it, Dreggy. Can you put all the follow-up replies between me and qqueque83 from that post on this board as well. Even Rapp's replies would be pertinent to this issue. There are at least 8 replies or more.
Thank you, Dreggy.
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Post by dreggy on Aug 22, 2013 23:25:03 GMT -5
qqueue83 • 12 hours ago Flag2
users liked this posts users disliked this posts 2 Reply silentbobsilent.Silentbob's analysis was based on MNKD's hypothesis which was proven incorrect in 171.
"One advantage of Afrezza is that it has much lower hypo risk, so you can manage your patients at a much lower A1c if the doctor chooses to do so (that will require some time)."
In trial 171, the FDA allowed MNKD to bring in an independent monitoring committee to make certain clinicians were dosing basal high enough to highlight the benefits of Afrezza's short tail. Management stated repeatedly that proper (higher) basal dosing along with Afrezza's short tail would "drive A1C's considerably lower" when compared to RAA.
The problem is it didn't happen.
Now we’ve gone from talking about superior 171 results, paradigm shifts and gold standards to talking about how the longer lifespan of red blood cells caused A1C readouts in Afrezza to be 1.9x higher than RAA in 171
rapp78 • 7 hours ago Flag1
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.Oh, How the Mighty Have Fallen. Good point. On their third try no less. Also, Bob admitted in cc that Afrezza arm did in fact receive more basal than aspart arm, so I'm waiting to hear the next excuse. What will they blame the poor results on now? DB was only 20 U per dose when it should have been 30 or more? Explain that to the FDA. I'm sure that will help with the bio = argument.
All those who bought into the "Afrezza is superior because it has a shorter tail" marketing campaign will soon realize it is the shorter tail which makes Afrezza worse than RAA's not better.
The longs: "But wait Rapp, Afrezza mimics the natural pharmakinetics of a healthy, non diabetic pancreas . . . it must be better." Again, another marketing slogan derived from Al Mann. But not true.
A healthy pancreas does not stop producing insulin after 2 hours. It keeps pumping out insulin as glycogen continues to be converted into glucose. This happens well after the 2 hour mark. In fact, it happens all day long, 8-12 hours, into the night, etc. It never stops. There is a reason why Lilly and Nova spent billions on the length of the tails in the current analogs. Those (aside from the small gap still needed at initial response) more closely mimic the natural pancreas, not Afrezza. You must analyze insulin from both sides, not just the start, but also the finish.
This is why Exubera had such better efficacy that Afrezza. Exubera's tail was 3X as long as Afrezza's and it's A1c's were 4x as good as Afrezza's. It had delivery mechanism and cost problems, sure, but it's hexameric pharmakinetic profile was far superior than Afrezza.
It's initial response wasn't quite as quick, but it lasted a lot longer on the back end which made it far superior.
cscorona84 • 7 hours ago Flag0
users liked this posts users disliked this posts 0 Reply .Yea the more I talk to Rapp about this (and I've been asking a lot of questions trying to find holes in his logic), the more I'm convinced the trial was a real failure in that regard. In Al Manns own words he set the lower A1Cs as an extremely important endpoint to obtain FDA approval, and it didn't happen even with the special basal titration. My guess is internally management and the study team are probably floored by the results they got and are in a bit of a panic mode.
rapp78 • 6 hours ago Flag0
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.CS, here is one of the posts I was talking about. Wrote it 2 weeks prior to data release. sounds fairly prophetic now.
Aug 1, 2013 12:37 AM
1 users liked this posts users disliked this posts 1
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You could be right ieter. I've appreciated much of your analysis over the past few weeks. I am predicting a .1 improvement in Aff 1 and .8 in Aff 2. I do think there will be more hypo events for Afrezza arm in Aff 1 than is generally expected, but both trials will meet primary endpoints sufficiently enough for MNKD to claim that the trials were successful. (Although 009 and 117 were deemed "successful" by MNKD in their original data release and turned out not to be so successful from partnership or FDA points of view).
Likewise, I'm more concerned with dosing, bio-equivalence and safety perceptions from potential partners and the FDA than I am with MNKD proving non-inferiority in 171 and superiority in 175 from an A1c perspective.
Most people think the data release in August will be either really good or really bad, but there's much more likelihood that the results will fall somewhere in between. Some positive points, some bad points (i.e. hypos), and some questions re bio equivalence, dosing, labeling and clinical utility that persist throughout remainder of year. Most people think the stock will go much higher or go much lower upon data dump, but it could remain relatively flat depending on the questions that remain.
Anyone else share these concerns? Can pulmonary & CV
rapp78 • 6 hours ago Flag0
users liked this posts users disliked this posts 0 Reply
.cs,
Exactly. Compare Al's usual jovial self with his demeanor on the cc and that should tell the story. My first hint of the poor results was when Al mentioned on Q1 earnings something about the "weaknesses of basal." Right then I said, uh oh, sounds like Al is hedging. I had been preaching on here in May and June about the weaknesses of basal and since 171's success was dependent upon more affect from basal that's when I began to worry. I had predicted a .1 when everyone else was expecting a .5 or better, but his comment about basal weakness started to give me pause and confirm my suspicions.
The second hint was when they announced (late July, early August) the new study for 30U of Dreamboat. I wrote on here in June that MNKD will very likely publish "positive results" but results may leave more questions than answers (I knew the history of MNKD calling both 009 and 117 positive but how they were rejected). I'll have to re-paste that post. I'm quite proud of that one. A bit prophetic if I can say so myself.
As soon as the PR's were released early on the 14th my eyes scanned down to the between group difference numbers and I was shocked. I had to read it like 5 times to make sure I wasn't seeing things. Aspart was 1.9 X better and Afrezza was only .06 from exceeding .40 inferiority threshold! Holy shit! And only a .4 on 175! The stock was up 30% and I was selling as fast as I could. Not all, but a lot. Glad I did.
dale_platt • 8 hours ago Flag0
users liked this posts users disliked this posts 0 Reply .Qqueue83,
What do you think about an approval for Type 1 diabetics with a restrictive label for them, and an outright cleaner label for Type 2s, as long as the Medtone results aren't too skewed?
What do you suppose the Medtone results looked like?
qqueue83 • 7 hours ago Flag0
users liked this posts users disliked this posts 0 Reply .Hey Dale,
I'm guessing Medtone outperformed Dreamboat. If Dreamboat would've outperformed Medtone, I imagine the company would have released that data in order to say "told you so." Instead they just said the results were comparable. If Dreamboat performed better, it would've been very easy to let the market know.
The path to approval for T2 seems straightforward given the results in 175 but the results from 171 could complicate this (non-inferiority aside, the results were far from what management was predicting and since the FDA had involvement in trial design, the results are likely not what they were expecting). Would T2 approval and a T1 CRL be possible?
I’m interested in other opinions on this. What do you think, Dale?
dale_platt • 7 hours ago Flag0
users liked this posts users disliked this posts 0 Reply .Yes, Qqueue. I agree.
I saw you posted this same sort of question to OPC11. I think the FDA might look at all the great years of good work to prove the safety of the Technosphere molecule, and then they could justify giving MNKD the nod to using Afrezza on Type 2 diabetics. Afterall, Study 171 bridged most of the gap between the two inhalers including pulmonary function, cadiovascular, etc.
What about the problem with bioequivalency though, qqueue?
Let's get that statistician's opinion on this. The last part of his poster name was dawg. I'll give him a shout out now and hopefully he will respond back.
Here's another point, qqueue.
I didn't remember hearing Bob say the results for Medtone and Dreamboat were comparable. That gives me hope for a Type 2 approval.
You see any more holes,qqueue?
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Post by daleplatt on Aug 22, 2013 23:56:19 GMT -5
Thanks Dreggy. I see you're not online now, but Goyo is.
There are 2 final correspondences between qqueue83 and me at the very, very end of this post. Goyo, could you pull them up from the silentbobsilent post authored by qqueue83 and post them here? One is qqueue's response to about Mnkd's conference call (Bob) talking about the word comparable. The other post is my response back to qqueue83. Again, it's the last part of the entire post.
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Post by daleplatt on Aug 23, 2013 1:24:30 GMT -5
There is a 'very interesting' rebuttal to the silentbobsilent post.
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Post by liane on Aug 23, 2013 5:58:23 GMT -5
Here's the remainder of the thread (I think) 1 Reply to dale_platt dale_platt • 13 hours ago 0 users liked this posts users disliked this posts 0 Reply Here's another point, qqueue. I didn't remember hearing Bob say the results for Medtone and Dreamboat were comparable. That gives me hope for a Type 2 approval. You see any more holes,qqueue? 2 Replies to dale_platt dale_platt • 11 hours ago 0 users liked this posts users disliked this posts 0 Reply That's very helpful, qqueue. Thank you. Since your Silentbobsilent post won't go to the top of this MB, this conversation needs some breathing space with as many open-minded posters as possible. What do you say if we go to the MNKD.proboards.com and discuss it? We would need to repeat exactly what we have said up to this point to start anew. Okay? Less qqueue83 • 12 hours ago Flag 0 users liked this posts users disliked this posts 0 Reply Ian Somaiya-Piper Jaffray “Hi. Thank you. Thanks for taking the question. It's Matthew on for Ian. So, just a couple, and congratulations on successfully meeting the primary end points. First, in the type 1 trial, could you provide us the press release gives A1c reductions for the second generation device as well as for the NovoLog group. But can you give us a comparison of how either the first generation and second generation devices performed relative to each other or tell us how the first generation device performed relative to NovoLog?” Robert A. Baughman- Senior Vice President, Clinical Sciences “Yeah. What I can do, Ian, is just share with you that the MedTone device performed comparable to the TI Gen2 data. So we do not see an appreciable difference between those two.” Less |
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Post by liane on Aug 23, 2013 7:42:34 GMT -5
Dale,
I copied the remainder of the YMB thread over here - but the format is a bit confusing. I also saw the thread by harshal on YMB "Reply to Crap in "silentbobsilent" post". At this point, I'm very interested in what you and the other posters there have to say, but I'm also very confused trying to follow it. My suggestion, if you could, would be to start a new thread here. Maybe you could summarize everything so far in the 1st post and then we could all get up to speed and carry it further. Thanks!
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Post by daleplatt on Aug 23, 2013 9:23:24 GMT -5
Liane, I'm continuing to decipher exactly what Harshal's rebuttal to the silentbobsilentbob article really means. I've been up most of the last 4 days trying to decipher the trial results. To help the situation, in the silentbobsilentbob post, re-read only the conversation between qqueue83 and me - disregard the other posters. There is 1 more comment from both of us missing at the end of the post, so click onto queue's screen name on the MB and then mine to see what was said. Silentbob's red blood cell analogy with regard to affecting A1C's was written several years ago, which confuses qqueue83's initial statement of his post. Plus, I have to meet my mother today. I promised her.
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Post by daleplatt on Aug 23, 2013 9:30:02 GMT -5
Sorry, Liane, in my haste I see where you found qqueue's last response recording what Bob said on the CC. My last post was just my personal opinion about Bob's 'comparable' comment. Click my screen name over there to see my opinion, which is just one small voice among many, many posters.
P.S. Harshal's rebuttal silentbobsilentbob post has merit as well. Afterall, inhalable protocol studies are his expertise as far as he stated.
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Post by daleplatt on Aug 23, 2013 9:32:53 GMT -5
OOOPPPSSS! You left out Robert A. Baughman's most important 'comparable' comment. Go back to qqueue's screen name to read it and re-post the rest here.
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Post by liane on Aug 23, 2013 9:42:12 GMT -5
I think this is what you want Dale:
qqueue83 • 16 hours ago Flag
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Ian Somaiya-Piper Jaffray
“Hi. Thank you. Thanks for taking the question. It's Matthew on for Ian. So, just a couple, and congratulations on successfully meeting the primary end points. First, in the type 1 trial, could you provide us the press release gives A1c reductions for the second generation device as well as for the NovoLog group. But can you give us a comparison of how either the first generation and second generation devices performed relative to each other or tell us how the first generation device performed relative to NovoLog?”
Robert A. Baughman- Senior Vice President, Clinical Sciences
“Yeah. What I can do, Ian, is just share with you that the MedTone device performed comparable to the TI Gen2 data. So we do not see an appreciable difference between those two.” Less
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Post by liane on Aug 23, 2013 10:30:03 GMT -5
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