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Saturday, April 08, 2017 2:59:59 PM
Thus, we arrive at new drugs already approved for first&second line pancreatic therapy encompassing monoclonal antibodies, topoisomerase, kinase, and other cancer regulatory pathways are not the latest technology. Even though some have been approved in the last 10 yrs. Instead activating a pro-drug like ifosfamide dating back to the early 1990s is the "latest technology". Uh huh.
Wrong. Again. Pre-IND meeting has already taken place and the company has even been afforded the opportunity to upgrade the trial to pivotal status. IND is coming, nothing mythical about that.
Once again you are mixing up IND vs NDA. An IND is the FDA's go ahead to conduct a trial. A NDA is a FDA approval to market the drug. To claim a NDA as in pure speculation has been put into place between PMCB, and some mystery big Pharma isn't even reality. There has been no FDA NDA grant, much less the IND. Noted there were no links provided with some Pharma announcing an imaginary agreement with PMCB. In the real world both companies announce such agreements. In the Microcrap world, it's always a secret.
IND is coming, nothing mythical about that...IND applications require preparatory time, especially for a clinical trial which had originally been designated exploratory in status to pivotal status.
Nonsense. Management has been pumping the pre-IND since 2014. They retained the TDers in 2014. Yet 2 yrs later, they spend the last months of 2016 pumping up a pre-IND meeting. And now they need how many more months (years)? Or did the FDA raise concerns management hasn't disclosed? No, having the statisticians crunch data at 6 months, takes no special planning as opposed to doing so at 2 yrs.
The Jewel of the Mind is Colored with the Hue of what it Imagines
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