RE:Nothing like some 'leaks' on the FDA ResubmissionPerhaps more related to them telling the story at the conference they were at this week. I do believe they will use the submission of a new protocol to talk to the market about where they are, which frankly we sort of know on that program anyway. So that alone is not some major market moving event. It's probably they talked about being a $90mil mkt company with that in revenues and some things percolating. It's not too hard to make a value case, even if just for a trade for a year.
I would love to hear a lot of the facts around what they learned with the 36 or so patients that informed the new protocol and why they think the issues identified by the investigators are at least addressed under their hypothesized science understandings -- the hows, whys, etc... Markets can understand those kind of complex discussions around how outcomes changed the protocol. But I also don't think you can really say anything about that in a specific way until you actually get the approval from the FDA in 30-40 days. It would be very premature to talk about it without it being the solid, accepted step to move forward to get another set of questions answered with enrollees. So do not expect details, just a --"we answered all the FDA questions, we reviewed everything in the committee of experts to optimize and increase out chances of success, we're committed to seeing this through the dosage and safety trial and learn about efficacy vs. risks, etc... They may talk the same general points they've already told us, maybe with more meat to it -- the fact they do believe certain pre-screening will be very helpful both for some things they learned around resistance, pre-treatments that subvert the drug, more higher sort1 type cancers, less severely treated patients, etc.... We should get those general statements.
What I'd love for them to talk about at this time is not just that they are submitting this new protocol to tease out more efficacy hopefully, but what they're moving quickly on around the whole platform --that's something they CAN do and SHOULD do --. are they ramping fast with SN38 or SiRNA, if so timelines? Moving rapidly to talk to partners on combos for immunologicals and platin drugs in certain tumors, moving ahead exploring the anti=metastatic traits, what they're doing with all the breast cancer reserach they've uncovered, etc.... Start building this as a platform and not just this one docetaxol dosage trial. What's the plan -- once again, the pipeline is bizarrely taking away value and is in real need of a concerted effort to turn that perception around since the science has moved into some potentially productive and rewarding areas in the last few months. Build up the whole sort1 environment and how you will do it cheaply with partners.