PharmaCyte Biotech Inc (PMCB)

[efood125]

Fact is...

Cell in box for an unmet need is a needed treatment for pancreatic cancer as there is no other available at this time...this technology happens to be very complicated and required a lot of testing to get it to FDA doorstep ...there are also successful test results from previous clinicals that FDA had to review...they have already asked waggs questions on 5 occasions during the 30 day review period...my take on this is that FDA still have other questions for waggs to address before approving and simply ran out of time...that's why a hold was issued by fda...so when the rest of the questions are answered we can move on to clinical trial...keep in mind cell in box is not a drug... just a delivery vehicle to site of tumor. Also cell in box requires only 1/3 the normal amount of chemotherapy to treat this cancer...so I don't think FDA is worried about effect of drug as it is already approved for use by fda... I think it all comes down to FDA wanting to clearly understand how this technology works.