Pharmacyte Biotech Inc (OTCMKTS:PMCB) Soars, Opens Floodgates For Catalysts

A couple of weeks ago, we published this piece, highlighting the potential of Pharmacyte Biotech Inc (OTCMKTS:PMCB) for near term gains. The company had a tough 2016 to that point, but looked set to reverse on the back of some fundamental development announcements, and our thesis was this: it's undervalued because it hasn’t released many updates, but just that it hasn’t released lots of updates doesn’t mean there isn’t work going on behind the scenes to add value. Moreover, we believed this work was poised to start bearing fruit and that any operational updates that did hit press would have a higher impact than they otherwise might, based on their relative scarcity.The primary near term catalyst we were looking for was the announcement that the company had secured a meeting with the FDA to discuss the IND application – an application that requires approval before Pharmacyte can move forward with a pivotal of its lead asset, the Cell in a Box system.Well, Pharmacyte just announced that this meeting is secured, and the company – as expected – has run up considerably on the back of the announcement. Here's the release.There's been no date submitted to shareholders as yet, so exactly when the meeting will take place is a little unclear, but the assumption is that it will come at some point during the first quarter of 2017, heavily weighted towards the first four to six weeks.To quickly touch on what's at stake here, the company has developed the above mentioned Cell in a Box system as a way to improve dramatically on the current SOC treatments in oncology. It's being billed as 'chemo without the side effects' and works by using a pre-injected activator cell, in a box like system, hence the name, located close to the cancer being targets. The cell activates the chemotherapy agent, as opposed to the normal process, which requires a cell that exists in the liver to activate it. The necessity for a liver pass as an activation process means current chemo is highly unselective, and in turn, highly toxic. By making it more selectively targeted, and eliminating the requirement for a liver pass activation, Pharmacyte is essentially trying to replace chemotherapy as SOC in solid tumor treatment. That’s a big claim, but the potential is real.The first target application is advanced pancreatic cancer, and the company is looking to advance its drug into a pivotal trial investigating its impact on patients in this indication. The IND approval precedes this trial, and therein lies the importance of this meeting.So what's next?The IND meeting is a place at which the FDA will answer questions surrounding the pathway to regulation (trial protocol, data necessity etc.) and – vice versa – the company will answer questions surrounding the current state of the trial setup, etc.Once the meeting completes, Pharmacyte will go away and put together a proposed protocol for the pivotal, bundled together as part of an IND application. It will then submit the IND application to the agency, and await a response. The FDA generally has thirty days to respond to the application. If it asks any questions of the protocol, Pharmacyte will have to go back and address them, and this will delay the process a bit. If within the thirty-day period the FDA doesn’t have any questions, the company is essentially good to go with its pivotal.The bottom line here is that the IND meeting is going to be the start of a flood of significant steps forward towards commercialization, and given the company's track record, we expect nothing but a substantiated, focused news stream over the coming few quarters. Each of these has the potential to inject double digit gains into its market capitalization, as the two latest have shown.One thing to keep in mind is dilution. The company has a low cash holding, and it's going to have to raise to fund the pivotal. Shareholders are going to bear the brunt of this raise by way of accepting dilution on their share holdings.We will be updating our subscribers as soon as we know more. For the latest updates on PMCB, sign up below!Disclosure: We have no position in PMCB and have not been compensated for this article.