Pharmacyte Biotech Inc (OTCMKTS:PMCB) is looking forward to achieving some major milestones in time to come. The shareholders have a lot to gain if the company achieves its set targets.
This business guru says 2020 is its year since it is time it hopes to achieve these major milestones. The milestones to be achieved are in line with the company’s leading therapy for the locally advanced, inoperable pancreatic cancer (LAPC).
Investors hoping to benefit from the achievement of milestones
Investors in the stock continue hoping for a price appreciation as the company upholds its focus, achieving the milestones. The company’s Investigational New Drug application (IND) is set to reach the FDA any time soon. This is the first milestone that the shareholders expect to be achieved this year.
Pharmacyte requires approval from the body to engage in the administration of the product. It will be in the company’s Phase 2b clinical trial that it will be administering the product to the patients.
The submission of an IND a few weeks later will be followed by another major development. This will probably be the achievement of the second milestone, which is the FDA’s response. A positive response will see the business guru start the clinical trials of the product.
The IND and matters surrounding it
Upon receiving the IND, the FDA will do as it usually does with the other submissions i.e. notify Pharmacyte. It will do that through an IND letter of acknowledgment. Usually, the FDA has about 30 days to review the submission and offer a response.
However, some things would result in the body doing things out of the ordinary. This is when the FDA realizes that the application in question is subject to some clinical hold. In such a case, the body is left with no other choice but6 to collect more information.
The business guru will be looking forward to seeing the IND go through. This will probably mark the start of shipping the product to the various investigators outlined in the IND application.
The prevailing condition has always been for the investigator to wait until the FDA approves the IND to take the next move. That would probably be the delivery of the therapy to humans.
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