AveMaria, let me try and shed some light on this one, but before I do...please note I am not in the industry, you must do your own research and simply do not rely on anything I say or have found.
Standard disclaimers aside, the real differences between Phase 2 and 3 are as follows
1) Phase 2 really aims to assess the safety of a drug. Its done with a larger group of patients compared to Phase 1.Patients are watched carefully.
2) Phase 3 is usually broken up into two trials and has a much greater number of patients, usually 1000 plus. The reason for such a large number is to try and rule out a greater number of combinations of different people, eg elderly, youngsters...sick,not so sick etc etc. However, as I have discussed previously ( https://hotcopper.com.au/threads/fast-track.4780603/?post_id=38745514) this can be over ruled to some degree if there is an acute need or this drug is servicing some large unmet need.(reminder: the current std of care results in massive drug over dosing and deaths!)
3) It may seem there is "not much left to prove" BUT Phase three also attempts to garner information about the effectiveness and the effects on populations using different dosages and sometimes even combining the effect of the drug with other typical drugs that many patients may already be on.. Eg in our case, OA affects more of the elderly population, there are greater chances that such a sub set of the population may be onblood thinners due to heart disease...how does PPS work in this environment? Are there any detrimental effects of combining PPS with some other drug...the more I think of the infinite combinations, the more I appreciate the fact at this entire process "ONLY" takes 2 years or less in the case of a fast track.I too am impatient, I want the sp to rise quickly...but, lives are at stake, we need to have this fully tested and certified before released and of course before we can make a decent profit out of it...it has to be safe and proven so.
Phase three's real aim to to compare the proposed drug against current standard of care. Yes Paradigmers, in this case we should be fine. The competition has so many side effects and we have gone thru many hoops so far to get to this point. No wonder Phase 2 is such a big hurdle, it really was good news, and imagine, three indications! (OA, RRV and MPS).
Ave Maria I cannot comment on PAR's unique endpoints as I don't know them and this would be internally held info, at this early stage I'm sure even they don't know fully....they are still putting it together, they will construct the end points in such a way as to utlilise the data they already have.Eg the biggest success seems to be the 4-7 stratum in terms of KOOS scores. This is the category that stands to benefit the most. Yes of course the other segments will benefit, but for a 3rd phase trial we want the biggest bang and highestchance of success...then we can worry about the rest and the finer details and caveats. I do know that typically they will be presenting more than 100,000 pages of data to the FDA, I also can tell you, from the following of CUV that I have had recently, that the staff of PAR will be under the pump, they will be doing a LOT of extra hours at work...I hope they get compensated adequately, I'm sure if they, like us, have shares they will be set. (my opinions, gotta remind you here of that).
Odds of success? 70% to 90% of drugs that enter a Phase 3 will pass1. ....so that's good news for us! It will be an involved process, it will be a long process but I personally feel we have a great chance of success, the only thing is that we have to be patient...again i see that the beginning of the Phase 3 of OA is pushed back slightly to Q4...I conservatively would say, even with a Fast track designation, it would be a good 2 years from Q4 announcement (IF it is Q4!) that we get the commercialisation go ahead...there would typically be a SP appreciation at least a few months in advance of this date so thats something to look forward to in the case we dont get a Phrama deal before that. Also, we have other pots on the stove...great situation to be in.
Paradigmers, we are in good hands...be patient..the end prize is within a few years!
(20min delay)