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Thursday, April 03, 2014 11:16:25 AM
Why would Angel, a 5 person, phase I generate a "partner", when BHRT has a phase III called "MIRROR" sitting out there (as well as Marvel - for what, 4 plus yrs now) that has generated no "partner" to date? Why?
Details of why a 5 person, phase I generates a "partner" when phase II/III's do not would be fascinating IMHO? Really love to hear how that works?
Getting from a phase I, such as Angel, means typically about another 3 to 5 yrs and about $10's of millions, to perhaps as much as $100 million or more, from even being close to having a chance to submit to the FDA for approval IMHO? Those are typical industry numbers I believe- can cite references, typical cases if needed.
For example- Baxter, who has literally $100 of millions, if not a $Billion or more in cash at their disposal, has a phase III "stem cell" and "heart" related trial, registered and in progress right now, on clinicaltrials.gov.
They are in phase III, 41 U.S. based "sites" (hit tab on .gov web site and you can see location of all 41 study/trial sites) and yet they list on the .gov site they don't even expect "results", let alone an actual "submission", until 2016- two more yrs away. So, what is a 5 person trial from Mexico supposed to do, and when and how? Why does someone want to "partner" based on that? Why? Just interesting to me, IMO?
http://www.clinicaltrials.gov/ct2/show/NCT01508910?term=baxter+stem&rank=9
Enrollment: 291
Study Start Date: April 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
That's BAXTER w/ 60,000 or so employees- see the dates. 2012 to 2016, 4 years they are expecting for their Phase III, to even get "final data", let alone does it even work, turn out good, get submitted to the FDA, let alone does the FDA ever even approve it. That is reality-ville of FDA trials IMO. As reality as it gets IMO. Those are "typical" industry numbers from what I have seen and read.
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