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   Biotech / MedicalARADIGM CORP. ARDM


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To: keokalani'nui who wrote (198)5/5/2004 6:36:13 PM
From: Area51
   of 255
 
<<Could be that this is limited to T1, as they have substantially more circulating abs at baseline. However, the T2 study originally planned to start this year will be delayed until they figure this out.>>

I gather this is the critical question. Since the market has cut ARDM price in half it seems to say that there is a 50% chance that the product is still marketable to type 2 diabetics (which are more than 90% of all diabetics or so I understand).

Since you sold I guess you think that there is less than a 50% chance that the product will be marketable to type 2 diabetics?

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To: Area51 who wrote (201)5/5/2004 7:52:21 PM
From: keokalani'nui
   of 255
 
I have no idea why you think I think this drug has a <50% chance of success in T2 diabetics.

I sold stock I had owned all of 30 minutes because I didn't (still don't) think there is any profit owning the stock ST/LT.

Hope I'm wrong.

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To: keokalani'nui who wrote (202)5/5/2004 8:35:28 PM
From: Area51
   of 255
 
Hi Wilder,

Sorry I wasn't trying to put words in your mouth. I was only trying to understand your perspective, as you are obviously more knowledgeable than I on the science.

My perspective (which may very well be seriously flawed) is that if the ARDM product can be marketed for type 2 diabetes, that it would still be a compelling long term investment now. So I was trying to get any insight you had on whether or not it was likely or unlikely that the product would be marketable for type 2 diabetes.

Best Regards,
Area51

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To: Area51 who wrote (203)5/5/2004 10:53:42 PM
From: keokalani'nui
   of 255
 
There is just no way of knowing. I'm convinced not even novo knows. But the lead suspect, if proven, will imo be the end of the drug.

You can be also sure that it's in trouble since only a few more months and they would have had the 24-mo safety data, but they stopped the trial anyway. Would fda require 24-month data for a T2-only NDA?

You are right about the payoff however.

I don't know so much about science, btw. Could save you or make you some money knowing that. ;-)

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To: keokalani'nui who wrote (204)5/26/2004 11:45:40 AM
From: tuck
   of 255
 
Recent freebie editorial on inhaled insulin:

bmj.bmjjournals.com

Notable for the sentence:

"Formation of anti-insulin antibodies is higher with inhaled insulin, and although this is dismissed as not affecting insulin requirement over time, older diabetologists will remember the drive to reduce insulin antibody formation, with the fears that antibodies delay and render unpredictable insulin absorption and even that antibody-antigen complexes may increase risk of microvascular disease."

I think this will torpedo Exubera, too, unless long term study data that does not reflect the Novo/Aradigm experience is also submitted. I hear that relevant study data was submitted by Pfizer to EMEA, but I thought these long term studies were still ongoing.

Cheers, Tuck

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To: tuck who wrote (205)5/26/2004 4:14:43 PM
From: keokalani'nui
   of 255
 
Nice, very nice, work. Might see if there is a footnote to that quote.

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To: keokalani'nui who wrote (197)6/7/2004 2:56:58 PM
From: tuck
   of 255
 
INHL' studies continue to show no effect, but night time glucose levels not measured? Would the FDA ask for such data? Two year results coming soon, should be interesting . . .

Message 20200796

Cheers, Tuck

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To: tuck who wrote (207)6/7/2004 4:07:53 PM
From: keokalani'nui
   of 255
 
tuck, apparently7 exubera shared l/t safety and efficacy at ADA today. I didn't focus on it and probably won't since I got no dog in the fight.

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To: rkrw who wrote (196)6/9/2004 3:21:01 PM
From: tuck
   of 255
 
It would appear that night time glucose levels, which derailed AERx, weren't measured in Exubera long term safety studies. From this year's ADA meeting:

>>Sustained Long-Term Efficacy and Safety of Inhaled Insulin during 4 Years of Continuous Therapy

Abstract Information
Abstract Number: 486-P
Authors: JAY SKYLER, FOR THE EXUBERA® PHASE II STUDY GROUP
Institution: Miami, FL
Results: Inhaled insulin has shown encouraging efficacy and safety data in short-term clinical trials. This study examined whether these favorable results are maintained in the long term. Continued open-label inhaled insulin therapy was offered to patients with diabetes who had completed any of three 3-month, randomized, controlled clinical trials (type 1, insulin-treated type 2 or type 2 diabetes uncontrolled on oral agents [OAs]). A total of 204 patients entered the extension, with 159 electing to stay on inhaled insulin (INH) or switch from comparator treatments and 89 patients having received at least 4 years of INH therapy. A small group of patients (n=23) on OAs or subcutaneous insulin was followed for up to 2 years as well. Mean (± SD) HbAì1cí was 8.23 ± 1.21% after 4 years in INH patients compared with 8.71 ± 1.49% at the start of INH treatment. Inhaled insulin dose increased slightly from 0.15 mg/kg after 3 months of treatment to 0.18 mg/kg after 4 years. The rate of overall hypoglycemia decreased from 2.58 episodes/subject month (first 4 weeks of INH treatment) to 1.50 after 4 years (final 6 months). Annualized changes in the lung function parameters FEVì1í and DLìCOí (mean ± SE) in INH patients over 4 years were -0.057 ± 0.004 L/yr and -0.376 ± 0.067 mL/min/mmHg/yr, respectively. Corresponding declines in non-INH patients (based on 2-year data only) were -0.071 ± 0.023 L/yr and -0.673 ± 0.423 mL/min/mmHg/yr, respectively. In conclusion, glycemic control and pulmonary function are well maintained during long-term continuous inhaled insulin therapy.<<

So my question is, why has ARDM/Novo made this measurement while NKTR and partners have not? Will the FDA want this parameter? I would think that if the former thought it was appropriate to delay development while investigating this issue, that the FDA would surely want to look at it from all comers. I wonder what others are thinking. FBR downgraded NKTR today, but I can't find the rationale. The results appear pretty good, absent the above measurement.

Thanks for any thoughts from anyone on this.

Cheers, Tuck

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To: tuck who wrote (209)6/10/2004 1:24:55 PM
From: tuck
   of 255
 
Thanks to deeno for this ML report which mentions for the first time in the analytical domain (that I have seen) the ARDM/Novo experience as a potential problem for Exubera.

Message 20210503

Cheers, Tuck

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