SA hit piece; George Rho's comment

[liane]

seekingalpha.com/article/1828722-oramedss-success-in-type-1-diabetes-could-solve-novo-nordisks-problems?source=yahoo

I wasn't going to post this link to "Lily Munster's" latest hit piece. But check out George Rho's rebuttal.


"I don't like critiquing fellow SA contributors but it's really difficult to take your work seriously. You continually pump ORMP, a microcap with a minuscule market capitalization of $55 million and about $1 million in cash, while never missing an opportunity to bash MNKD, which is a far more substantial company, one founded and headed by a man who has already made major contributions to treating diabetes, as well as other health issues.

You're clearly not an objective analyst or else you wouldn't so freely use the loaded words that you do, such as "sins," "absurdity," "smoke and mirrors." And this list doesn't even get into the words you've used in previous articles.

Your comments about focus groups and NDA applications further underscore the lack of any professionalism (or perhaps common sense) in your article. Do you seriously believe that physicians would pervert their responses for a few dollars??? And why exactly would drug companies spend hundreds of thousands of dollars on market research if the research is as useless as you suggest??? As to the NDA application, have your ever even seen one???

You don't have a position in ORMP so it's difficult to understand your motivations. Oddly enough, too, your article, trashing MNKD, only shows up on the MNKD summary page. It doesn't even show on the ORMP page, which is supposedly the main subject of your article, let alone NVO, BMY, PFE, GOOG."

[spiro]

Liame,

Thanks for posting the George Rho response. It's interesting that virtually every negative article has to rely on the Exhubera comparison.  The apparent  weakness in these hit pieces is actually making me more confident in MNKD's  ability to get Afrezza on the market. I think doctor's will be more concerned with helping their patients control their disease, rather than worrying about Exubera's failure. Let me add,and saving their patients lives by reducing severe hypoglycemic events.

Spiro

[mannmade]

It is also my understanding (and for some reason not made clear by George) that even if successful Oramed's insulin pill is a Basal replacement and would therefor actually combine with Afrezza for a completely needle free treatment regimen and possibly become a great compliment for Afrezza. As for Exhubera someone should refer her to the article where the President of Pfizer's diabetes division said that Exhubera was fraught with mistakes and that Afrezza was a much better drug and delivery system and will likely gain approval by the FDA.

[liane]

Apparently, George's comments have been taken down from the SA site - don't know by whom or why. Lucky we have a copy here.

[liane]

George now has a comment up that he is NOT the one to retract the comment. Hmmmm!

[jpg]

The above article doesn't start off very well with:
patients' petulant demands for an alternative to needles and pens use up more of a doctor's limited practice time. 
Petulant? Since when are sick people wanting better medication petulant? Weird, uninformed and mean at best. Thinking of patients/ customers that way is not costumer centric to say the least...

I don't follow this company but simply from reading the link provided to the 8 patient non randomized trail (6 patients actually reported data) it seems obvious that this oral insulins have a long way to go...
www.plosone.org/article/info%3adoi/10.1371/journal.pone.0059524


From the results section:

In addition to full compliance with the study protocol, patients reported full adherence to their regular insulin therapy regimen during the study period. No adverse events or hypoglycemic attacks were reported throughout the study by any of the eight patients

From the conclusions of the study:
This study was not designed to address the question of whether the hypoglycemic action of the addition of ORMD-0801 to the subcutaneous insulin regime, results from a first-pass hepatic effect leading to reduced post-prandial hepatic glucose production or a cumulative peripheral effect of both s.c. and oral insulin on peripheral glucose uptake. Moreover, the small sample size, study design and short follow up period prevent us from reaching strict conclusions and can only be addressed as hypothesis forming for future larger and longer trials planned

A wise and safe conclusion but I would have added: 
There is a possibility that better compliance (in the 6 patients who did report data) to injectable insulin partially or completely explains the better glucose control observed in these few patients. If this were to be the case maybe our oral insulin has no biological effect.



The authors of the study themselves state in their conclusion that they don't know if this would act like a s/c insulin or work by first pass hepatic effect so hard to say if this would be a long acting oral insulin or an 'Afrezza like' mealtime insulin.  Not even considering if the insulin actually works I would guess that because of first pass effect (which the study says it did not explore or address) and the fact it is given 45 minutes before a meal and at every meal this formulation is for now being explored as being a mealtime insulin and not a long acting insulin. There is more to first pass insulin signaling then just being 'first pass' though. Concentration and bolus effects are important also. These nuances are beyond my understanding of the mechanics of insulin hepatic signaling but I would be very careful before assuming much from such basic and simplistic data.

Time and better studies (after better funding) will tell.


Again even if this latest version of oral insulin does work we are a long, long way from the market.

JPG

[jpg]

Tried reposting Mr. Rho's comment but they were taken down by SA a few minutes later.

So much for SA policy of open dialogue...

[liane]

Nov 11, 2013 18:03:46 GMT -5 jpg said:

Tried reposting Mr. Rho's comment but they were taken down by SA a few minutes later.

So much for SA policy of open dialogue...

They're still there - sometimes you have to click on a box at the bottom "Load all comments".

[liane]

And further from George Rho (such a classy guy):

To all the other posters:

I was disappointed to discover that my comment had been deleted. SA subsequently informed me that the reason was "it contains references to material that is unrelated to the topic under discussion." I've asked for specifics but have yet to receive a response.

At this juncture, I would not be surprised, nor particularly disappointed, if a response were not forthcoming. SA obviously had its reasons, about which we can all speculate, but there's probably little value to doing so (or trying) on this venue. Despite its shortcomings, I think SA is a valuable resource and my preference is to maintain a cordial working relationship.

Meantime, I do appreciate all of your support in trying to retain some sort of objectivity in viewing MNKD, in the face of so much clearly-biased negativity. (I certainly hope this comment survives.)

[otherottawaguy]

I tried to repost the commentary as well as a response to his "I didn't retract it..." got the following email notification which I am more than glad to share:

Dear OOG,
We wanted to let you know that we’ve deleted the post copied at the end of this email and explain why. It was deleted because it contains a personal attack on another user or contributor. Participation in the Seeking Alpha discussion community is contingent upon treating other community members with respect, especially when you disagree with their arguments or believe they have omitted or misinterpreted data. We welcome (or even encourage!) disagreement with the perspectives offered by others on the site, but please focus your response on why and how you disagree with the substance of the article or the comment you are addressing.

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