PharmaCyte Biotech Inc (PMCB)

[DragonBear]

This should help-it's only a catch phrase

After the IND process runs its course

A nice generality which sets no time frame for an IND filing. Leaves them many months of continued pre-IND nonsense. More months for insiders to enrich themselves with "compensation".

shareholders should be prepared for what a planned 6-month "hard stop" in the clinical trial could bring in the way of data to the industry. If past performance in earlier clinical trials is any indication

The only "hard stop" to a clinical trial is one in which the FDA shuts down a failed trial, with high morbidity.

What they are hinting at, and for some reason not wanting to state, is they hope to apply for "Fast Track" approval after 6 months of Phase 1-2 data. Although unlike the catchy phrase "hard stop", the words "Fast Track" have a defined FDA context. So why didn't they on 01-Dec announce they expected IND approval no later than mid Jan? With clinical trials started 30 days later, and the goal of applying for "Fast Track" approval 6 months later? Answer: Because they have no idea when or if an IND will ever be approved. Whether they will ever have the money to stage a clinical trial. And they surely don't know whether ciab+low dose Ifosfamide will be any better than the control arm of low dose Ifosfamide alone, assuming a clinical trial ever occurs.

Then again if the real goal is for insiders to continue to draw nice salaries, then everything else is noise. Keep an eye on the O/S.