Pharmacyte Biotech Inc (OTCMKTS:PMCB) released a statement by CEO Kenneth L. Waggoner that addresses the firm’s position on giving a date for submitting its Investigational New Drug application. Mr. Waggoner stated that the company does not intend to release a date for the submission of its IND.
The details
Presently, it’s extremely tough for the firm to supply an advancement timeline that will accurately estimate when the IND will be submitted. It would be negligent of the firm to release what, at this time, would be just a “hopeful” date for submitting the IND. This submission date could change depending upon numerous unforeseen variables, many of which can be beyond company’s control. It indicates that they cannot release an accurate timeline for submitting the IND because they too are looking for a list of to-do items of others.
What can be reported with certainty is that company is on the right course for filing its IND at the first opportunity. With the assistance of TD2 and Facet Life Sciences, Pharmacyte is committed to performing everything the right way by ensuing the guidance provided to the firm by the U.S. FDA during the pre-IND discussions.
In doing that, the company intends to increase the possibility of drafting a successful IND compared to having the firm’s IND put on hold or even outright repudiated because it didn’t trail the FDA’s direction. Getting to a place where the IND can be submitted is not a one-month or an overnight process.
During the conference call, this point was conveyed to shareholders. Any investor who considered that the pre-IND discussion would be closed one day and subsequently on the very next day, the IND would be submitted had completely impractical expectations.
Pharmacyte’s pre-IND discussion with the FDA can be stated as the best possible course for the firm to release its pancreatic cancer treatment, past clinical study report and trial plan to the FDA.
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