The "problem": the FDA did not beach of any contract. The law give a right to FDA to "rescind an SPA agreement when the division director or senior management determines that a substantial scientific issue essential to determining the safety or efficacy of the product has been identified after the trial has begun (section 505(b)(5)(C)(ii) of the FD&C Act." ANCHOR result (TG lowering) was not enough, substantial scientific issue (REDUCE-IT) was essential to approve Vascepa for TG 200-. No Court will decide against the FDA in a scientific matter …
by KCSVEN
Do you think new sales staff was the one and only reason behind the raise? What about: - buy inventory - finance daily operation - provide Vascepa for Canadian market (and for EU later) - refinance API capacity expansion (As they did in the past …) - etc. FYI: (usually) the costs come before the revenue. e.g. Ended 2019 with approximately $645 million in cash does not mean they were not or will not below $600 (/500) million at any time.
Does not make sense to bickering about the minimal level of sales reps but one thing is sure they did not hire additional 400 just for fun …
"right to market truthful information on the drug" [yes] "and yet JT is not exploiting it." First of all: we have to see pre- and after Dec 13 separately. pre-: Meanwhile they could talking (market truthful information) to health professionals they could not to customers … since the label did not included the information about ANCHOR (or REDUCE-IT) after: They will do it. … I am sure they have a valid reason to plan (start) it around mid-2020.
by Markipeach:
JT isn't a spokesman for Vascepa … he is the CEO of Amarin. I am not aware of any interview / speaking when he talked about Vascepa … he talked about Amarin (and as a part of Amarin, about Vascepa) … Reuters / etc. do not want to interview "sales", they make interviews with CEOs.
Cute …. but it is not how it works.
To avoid any doubt: I do not say the current pps is a funny thing … but see the forest, not the tree only … JT and the team building the Co. … Rome wasn't build in a day.