My take on the call was that the original IND was meant to be used for an in-house trial, but given Mayo received a large grant, they turned it back over to them for use for the 280-patient trial; and essentially now need an amended IND to get another trial set up for the initial protocol they were already working one (same sites, same PI, the original one they communicated a target start of Q3), hence the delay. Given the original IND is tied to a larger trial, they now need to collect peptide manufacturing for that Mayo TNBC trial, which will take time estimated Q1 2016, in addition to their own trial. Now getting back to those in-house trials they'll manager and pay for, well those include a variety of small open label trials. We will likely see several oncology proof of concept trials: a plain-Jane FRa to mimic the Mayo trial, TNBC but again on a smaller scale (may or may not include an agonist (toll-like receptor)); FRa + Checkpoint Inhibitor (likely w/Ovarian (my guess)); and then, a HER2-neu trial, but expecting that to be early next year. Anyway, we are not told which trial will come first. But, they will be announcing CI relatively soon.
In my view, this company will make good on their promises, they were just thrown a few months off track but over extraordinary news. This major grant -- bigger than industry norm --has essentially altered their strategic thinking and for the short term, their clinical direction. So while yes there has been a few months delay on the submissions on Orphan (Ovarian (TNBC doesn't qualify for Orphan status)) and Fast Track (both TNBC and Ovarian) because they need an amended IND to submit those (meetings with FDA, etc.) but the delay is temporary. In the meantime time value means something, the phase I data ages. :)
Honesty I don't think the Company could have ever imagined Mayo would receive such an enormous DoD grant. I do a lot of grant research (helps to understand the pipeline of what's coming) and data had to be scientifically strong to warrant the receipt of such a huge grant. Usually grants come in the $200-300k range, not in excess of 13.3 mm! The fact that people are swing trading the shares for a small gain, shows me that they don't understand the magnitude, it's unheard of for a small publicly traded biotech scientific partner to receive such an enormous gift. Other companies with strong data have tried to get a full scale trial paid for, and have failed. Generally the company's that do get significant grant funding at this early stage are the ones with the impeccable early clinical findings and they are not publicly traded biotech's. Instead they're backed and financed by a small number of private billionaire investors. The general market only gets to invest in those type of biotech's once they officially go public, which is only at an uplist point. Most of the money made on those stocks is priced in, so limited upside, unless you're one of the billionaires who financed upfront get in at the bottom. But that's not the case with Tapimmune, this year is our bottom. It is relationships that landed TPIV with collaboration partnership that is turning out to be a scientific technology clinical gifts (Knutson & Wilson). It is why they've been able to attract such a prestigious board who are being paid with an option to buy cheap shares. This Mayo grant validates that this investment opportunity upon us, is one that rarely comes along to the ordinary investors. On that note, I suggest this iHub not spoil it by treating TPIV like a penny stock. I know I won't be. If you do decide to swing it, I hope you use it to grow your position. I'm expecting the days of toxic financing are behind the undervalued biotech, and regardless of where this goes short term, the medium term view is a higher valuation as the float will be absorbed as the story of Mayo's trial gets press time (and it should, as October is Breast Cancer Awareness month) new investors will join this iHub and the stock price will head higher and ultimately be up-listed. Long term view is exciting and yes, that's up too. :)
