Quote: "There has been no FDA NDA grant, much less the IND."
Please help me understand exactly where I stated there has been an NDA filed. I have made no reference to an NDA in any of my posts. We have already had a very successful pre-IND meeting with the FDA. The next step is to file the IND application with the FDA, so the upcoming trial in LAPC can begin. No confusion here.
The delay is due to the FDA suggesting a pivotal trial would be appropriate.
This is a huge advance and saving for the company.
Pivotal trials have more patients and need extra planning so of course ind application will take longer but the whole process will now be faster and less expensive.
The patience shown in the pre ind preparation was a huge success. A landmark for the company.
The patience they are now taking to prepare for ind approval for a pivotal trial offers the same.
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