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Post by ezrasfund on Feb 7, 2014 10:14:33 GMT -5
There is plenty of good info to be found on the Yahoo MB if you can wade through all of the sewage. Here's an interview with Bill Doub, an FDA lead chemist, in OINDP News (Orally Inhaled and Nasal Drug Products News). Some interesting comments, but what he says about nanoparticles on page 3 shows he doesn't know about the pH mechanism that changes Technosphere from a powder to a liquid in the lungs, or, at least, he's not telling. www.oindpnews.com/2014/02/a-qa-with-the-fdas-bill-doub/ |
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Post by savzak on Feb 7, 2014 10:24:53 GMT -5
I saw that thread on Yahoo and searched Bill Daub. Check out this FDA power point presentation from a couple of months ago...
"Overview of FDA Research Interests in Dissolution of Inhaled Products"
ddl-conference.org.uk/files2/04.Lee.JPAG.2013.pdf
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Post by ashiwi on Feb 7, 2014 11:36:48 GMT -5
This is the most relevant quote from Bill Daub. VERY ENCOURAGING!
...I also think we’re going to be seeing more systemics. Up until a few years ago, there were no systemic inhalables or very few. Insulin sort of came and went in a flash, so . . . it’s coming back, yeah. Pfizer lost a lot of money on that project, and so I think it’s given some people pause to think about delivering protein drugs by inhalation; but you know, there are so many advantages to delivering drugs by that route I think we’re going to see more systemic inhaled drugs. And I think that probably it’s easier to deliver those drugs as dry powders than it is to try to get them to dissolve in HFA...
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Post by biotec on Feb 7, 2014 12:24:48 GMT -5
I cant find a date on this article, Does anyone know when it was published?
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Post by ezrasfund on Feb 7, 2014 12:34:45 GMT -5
I figure that it's very recent. If you go to the home page for OINDP News, where the article appears, and refresh it for the most updated main page, the article is still a lead story.
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Post by Chris on Feb 7, 2014 12:40:20 GMT -5
Hey all, for those of you wondering about the date, if it's not stated in the article it's usually visible in the http. This http says 2014/02, so year 2014 and month 2. www.oindpnews.com. ----> /2014/02/ <---- a-qa-with-the-fdas-bill-doub/ Regards, Chris |
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Post by biotec on Feb 7, 2014 14:46:34 GMT -5
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Post by Chris on Feb 7, 2014 15:12:50 GMT -5
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Post by biotec on Feb 7, 2014 15:39:16 GMT -5
Thanks Chris, Sounds like there still working on something. Ill have to go back and read more about it. The article said it was sold. Sounds like the inhaler is still being worked on as a dry powder (DPI)What was the short comes of the DPI?
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Post by ashiwi on Feb 7, 2014 15:50:31 GMT -5
MNKD is using their Technosphere technology for pain as well. Using the "Cricket" Device for pain/migraines is currently in trials with mice at Torrey Pines in Port St Lucie, FL. Once Afrezza is approved the flood gates will open for other Technosphere indications. The "Cricket" is smaller than Dreamboat and is a one time use device.
Management @ MNKD are very excited about the trials so far and think it could be bigger than Afrezza.
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Post by jpg on Feb 7, 2014 16:13:03 GMT -5
MNKD is using their Technosphere technology for pain as well. Using the "Cricket" Device for pain/migraines is currently in trials with mice at Torrey Pines in Port St Lucie, FL. Once Afrezza is approved the flood gates will open for other Technosphere indications. The "Cricket" is smaller than Dreamboat and is a one time use device. Management @ MNKD are very excited about the trials so far and think it could be bigger than Afrezza. What Torrey Pines is doing is a level above 'simply' using Technosphere. If their approach to pain work out (which is statistically unlikely) they would revolutionize pain management and this could be a super big blockbuster. I am by far an expert but from what I understand (and recall) of what they are doing their use of peptides instead of narcotics would change the paradigms of pain management in a very big way. Again this is far from being done but the early public stuff I have seen is exciting. |
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Post by nemzter on Feb 7, 2014 16:36:46 GMT -5
MNKD is using their Technosphere technology for pain as well. Using the "Cricket" Device for pain/migraines is currently in trials with mice at Torrey Pines in Port St Lucie, FL. Once Afrezza is approved the flood gates will open for other Technosphere indications. The "Cricket" is smaller than Dreamboat and is a one time use device. Management @ MNKD are very excited about the trials so far and think it could be bigger than Afrezza. What Torrey Pines is doing is a level above 'simply' using Technosphere. If their approach to pain work out (which is statistically unlikely) they would revolutionize pain management and this could be a super big blockbuster. I am by far an expert but from what I understand (and recall) of what they are doing their use of peptides instead of narcotics would change the paradigms of pain management in a very big way. Again this is far from being done but the early public stuff I have seen is exciting. "Imagine the Possibilities" Cricket for the flu-shot versus needles, no refrigeration, easy administration for kids, you can just buy it at Walgreen's and "inhale" at home. I'm still hoping Viagra will still come into play in the near future  |
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Post by babaoriley on Feb 7, 2014 16:55:57 GMT -5
Yes, nemzter, I would also love to inhale whenever possible whatever the market in general, biotechs more specifically, and MNKD precisely, was exuding today!!
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Post by Deleted on Feb 7, 2014 17:47:18 GMT -5
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