RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Val. lt following FDA approval: $3-4.5 Bil or $10 -$15 share I am a drug regulatory specialist from Quebec.
As others have said, either you`re insider trading, or you`re lieing. I have reviewed the data independently and see no reason to think they shouldn`t be successful. I have a deep understanding of drug approvals with the FDA and have experience with oncology drugs. There is nothing in any of the clinical data that leads me to believe an outright rejection, specifically if they have maintained a positive communication with the FDA to date.
The worst case scenario is a delay, and this would only occur if they didn`t followup properly on any FDA commitments requested through various IND ammendments. Typically, when Ph3 data is bad, the company cascades in a irrecoverable downward spiral very early on. I have witnessed this happened first hand with another Quebec company called Aeterna Zentaris. This looks like it isn`t the case at all.
Judging my perspective, I think they are on a very solid path.
Full Disclosure: I have recently purchased a sizeable investment in TST upon my independent due diligence, and review of the data at hand combined with my experiences in these matters..