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Post by tomtabb on Nov 23, 2018 18:44:09 GMT -5
I looked at UTHR's pipeline page and noticed that tre-t is on the medium term list -- www.unither.com/pipeline.html It appears to have eight nearer term and one medium term launches ahead of it. Number one -- the implantable system -- was approved in July but UTHR hasn't specified a launch date. So how far off are we talking regarding a tre-t launch? |
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Post by goyocafe on Nov 23, 2018 20:34:46 GMT -5
I looked at UTHR's pipeline page and noticed that tre-t is on the medium term list -- www.unither.com/pipeline.html It appears to have eight nearer term and one medium term launches ahead of it. Number one -- the implantable system -- was approved in July but UTHR hasn't specified a launch date. So how far off are we talking regarding a tre-t launch? They need to start Phase III first and it’s been in a “ready for Phase III” state for months. |
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Post by brotherm1 on Nov 23, 2018 21:49:58 GMT -5
Will it be ready for sale before Arena’s/United’s ralinepag?
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Post by matt on Nov 24, 2018 10:30:48 GMT -5
It is hard to estimate because you don't know what FDA is going to require for approval. In this case FDA will likely give a pass on a full Phase I and Phase II and require a short bridging study to establish safety of the new formulation. UTHR will still have to run a Phase III to demonstrate equivalent or superior results to the existing formulation. Time to complete development is all over the place, but the Tufts Center for Drug Development tracks all new drugs and has published these averages (all figures in months):
Preclinical laboratory and animal testing - 60.5
Phase I - 12.3
Phase II - 26.0
Phase III - 33.8
FDA Review and approval - 15.6
Total time to market - 148.2
As I said above, these are averages spread over several thousand drug, and there is a lot of variance in the sample so use these numbers as a guideline and not the absolute truth. However, if the new formulation is Phase III ready, and the company can negotiate a complete pass on the Phase I/II requirements, it would still takes about four years to reach the market for an average drug.
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Post by mango on Nov 25, 2018 4:06:18 GMT -5
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Post by boca1girl on Nov 25, 2018 7:19:05 GMT -5
Is it possible that the time line could improve with adequate funding that United would be able to provide?
The timeline presented by MNKD may have been conservative due to limited funds.
I have heard of trials stopping early based on excellent results. Is that possible in this case or pediatric trials of Afrezza?
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Post by Clement on Nov 25, 2018 8:41:51 GMT -5
The start switch is "nearer-term". I suppose that one of the conditions for Unither hitting the start switch would be MNKD being able to provide sufficient TreT in correct dosage forms for the study. Can we infer that the start switch would be followed immediately by a milestone payment? ... $25 million? |
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Post by peppy on Nov 25, 2018 8:47:17 GMT -5
The start switch is "nearer-term". I suppose that one of the conditions for Unither hitting the start switch would be MNKD being able to provide sufficient TreT in correct dosage forms for the study. Can we infer that the start switch would be followed immediately by a milestone payment? ... $25 million?  |
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Post by tomtabb on Nov 25, 2018 15:52:45 GMT -5
How much and what "deliverables" are required? Does it include the bluhale device? The UTHR CEO seemed to imply that was going to be part of the final product.
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Post by JEvans on Nov 25, 2018 21:52:47 GMT -5
How much and what "deliverables" are required? Does it include the bluhale device? The UTHR CEO seemed to imply that was going to be part of the final product. I though our boy Trump was working on reducing FDA oversight to make it easier for drug suppliers to get things approved faster and without breaking the bank to do so. Which ultimately would lower drug cost here in the great, make America better, USA |
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Post by tomtabb on Nov 26, 2018 9:26:33 GMT -5
Donald tends to get excited about a topic for a while and then just wanders off onto something else. Right now, I wish he would focus on resolving the trade "wars" since I think that's a significant part of the weight on the market in general.
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Post by liane on Nov 26, 2018 9:33:44 GMT -5
Let's please stay out of politics.
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