Hello again, and sorry for my own ramblings. We all have a say and that's the way it should be. Let's all take a breath, (or in your case a sleep) and look at the information provided to usvia the announcements. We must remember that we don't make the rules for Trials. We are playing the FDA's and other Regulatory Agency's rules. If they say paint the wall green, so be it. Paint it green and go to the next step.
I feel that the FDA summoned up the idea that the two trials based on different times and numbers are based on past requirements for similar types of trials. Below I have grabbed a few links to help explain costs associated with trials. These aren't cheap by any means, and they only get more expensive as time goes on. PAR got the word from the FDA that a DUAL Phase 3 trial would be needed. That translates to many more dollars, and if your stepping up to the plate you should be ready for what comes your way. Big dollars for trials? You need big backers and quickly signed, to show that your ready to play in the Big Leagues. If your worried about not getting the chance to participate with THIS CR, you most likely aren't a Retail Buyer/Seller, and should be complaining in your Board Room for not getting the chance. Sounds like PAR needed a quick response to the FDA challenge, and (to me)...sounds like they had a back up plan for this just in case. Imagine trying to scrap together some quick millions from someone just because......
We all have some questions, but I'm going to guess that none of us posting are truly knowledgeable enough to know all of the answers, and even what are good questions to ask. Second guessing PAR here, after my reading and understanding of how this is developing, is a non event. They have been very open and don't give out mixed signals. Paul Rennie will be asked about this in due time, but I think that he may be a tad busy himself doing what he and ALL of the PAR staff should be doing at this moment.
Informed investors know that he can't inform the shareholders of everything he knows, for good reason. (If there is something, that is.) Let the good people of PAR do their jobs and accomplish what they are there to do. Maybe we all have been eating too much sugar on the PAR sight, and are on a high. Let's see what reality looks like when we calm down and catch our breath.
Something that no one has mentioned, I think, that we may to keep in the back of our minds. The FDA could STILL....stop the future trials because of good results, together with all of the other known past historical information of iPPS, and give it's blessing before the expected end dates. I'm just sayin........... There's always hope folks.
Costs tended to be higher when a trial lasted longer or enrolled more patients. For example, the trials with fewer than 100 patients had an average cost of just $6 million, while the trials with more than 1,000 patients had an average cost of $77 million. Trial costs also varied across treatment areas, reflecting the varying difficulty of measuring and demonstrating efficacy from one disorder to another. Pivotal cardiovascular drug trials, for example, had a mean cost of $157 million, versus just $21 million for pivotal trials in endocrine and metabolic disease patients...see Johns Hopkins LINK BELOW:
(20min delay)