RE:RE:RE:RE:More Positive PressI agree with alot but clarify what you mean by "guaranteed".
If you mean that we are gauranteed a global deal then I dis-agree. This is the biggest single event on the horizon. As you say it hopefully will lock in a great deal of value. If it was gauranteed it would be reflected in the share price
If you mean it's gauranteed (necessary???) that we have to get a global deal before we go to Phase III then I agree. They need to cover the cost and do the hard work.
I dont agree with your somewhat cynical take on the fda about "clout". I'm prepared to believe the approval process is largely a rational one based on the interpretation of data, having the resourses to prepare a right dossier is important. Its definitely a dialogue between the two sides so experience and skill is going to influence the outcome, I dont know if thats what you are suggesting. You seemed to be suggesting something more manipulative.
Something I dont quite understand.
Put simply, I dont get why the next trial is so important to getting a global deal. In essense we have now a low dose NSAID with great gastric sparing and at the end of the next trial we'll (probably) have a low dose NSAID with great gastric sparing. Is the present pain control data not enough? Does some dose effect data add so much more to the story? Genuinely I'm struggling to quantify how much the next trial adds to the story. I understand that dose ranging is necessary technically for fda, that it informs the Phase III trial but that seems largely technical. SNAFUs aside, the worst that can come from the next trial is to proceed with 250mg dosing there seems little risk in that.
StrikingMoose wrote: I wouldn't be surprised to see a regional deal before phase 3 starts.
Actually.
We will be seeing a global deal before phase 3, guaranteed, from the horse's mouth (Legault) himself.
He said during the AGM that they will be exiting responsibilities with 346 after the pain data comes out, which makes sense. They don't have the power, reach, logistics, or cash to run phase 3 trials and to submit/influence an FDA decision. Don't forget, a big name has a lot more clout in with FDA to get drugs passed than a nobody which we are (to be honest).
A large pharma company will provide the ROI that we are all looking for, whether it's a buyout or a deal valued in the hundreds of millions which will be reflected in mkap. After that then it's left to analysts and the markets to assess the rest of the pipeline's involvement, if we get a 400M-600M deal for 346 (or even less and I'd still be happy) then don't forget to surmise future potential also.
Then we have to remember also what could be happening with citagenix. Canada sales are down but US sales are up to bring us almost flat with revenues which means US sales are actually growing at a good pace. If we become profitable they'll have a great company to sell to someone or to sit on and slowly enjoy a trickle of profits that also could be reflected in the market cap of the company. I think, esssentially, citagenix is valued at 0 in the current market cap which is unfortunate.