Pharmacyte Biotech Inc (OTCMKTS:PMCB) says that it will soon submit its Investigational New Drug application (IND). After submitting, the rest will be left to the U.S. Food & Drug Administration (FDA). This information has been making rounds, and many investors are closely watching.
PharmaCyte says that it was impressed upon receiving the information that Austrianova, which happens to be its partner, had completed the tasks it had been entrusted with. This was the encapsulation of the cells in the company’s Master Cell Bank (MCB).
A close outlook
The business giant has been channeling a lot of resources into its clinical trial product, hoping that it will turn out successful. It is targeting helping a large number of patients struggling with the inoperable and advanced pancreatic cancer (LAPC).
Kenneth L. Waggoner is the current Chief Executive Officer of PharmaCyte, and he says that he is happy with the steps made so far. He says that the encapsulation process conducted in the previous week at Austrianova’s facilities had run successfully. He admits to having taken some time to check out the pictures of the cells taken in Thailand and that things looked good.
The official hopes that everything turns out well with the second of the company’s two back-to-back manufacturing runs.
As a regulation, the FDA will see to it that tests are conducted on each of these runs. PharmaCyte is looking forward to obtaining the information about the testing, after which it will move ahead to incorporate it into its IND. It will then hand it over to the FDA.
Much has been accomplished
It is rather impressive that a great deal of what was to be done has been completed already.
The business guru knows the capabilities of Austrianova, and that is why it entrusted in with the massive responsibility. It was to run the two back-to-back manufacturing runs, and its success means well for PharmaCyte.
The decision that the FDA makes will mean quite a lot for this leading company. For instance, its opportunities for funding will have improved massively. Waggoner reveals that they have so far run and completed most of the tests and even engaged in the data entry activities.
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