PharmD price target fun, page-77

Yeah good question, my feeling is that it will heavily depend on how the patients are screened and thus selected.
When PAR asks for patients it wont just be any old random people (the first 1100 for instance), they will need to meet some certain criteria at leats for the bulk...there may be some selection though (see at end of this post)

Ok so Mozz, what was the criteria for phase 2 OA? Glad you asked:

1) Kellgren lawrence score had to be 2, 3 or 4.

(Rating of '1' is too low in terms of current OA), this is a world famous scale rating for degree of OA. Our drug has most effect for > 2)

2) Pain related to OA for at least 6 months

3) BMI could only be between 18 to 35 kg/m²

4) Females must be of non child-bearing potential

5) Presence of BMEL's which were to be confirmed on screening via MRI

6) Age must be within 40 - 75 years of age

7) No evidence of increased bleeding in the past

8) No HIV or Hep B/C in the past

9) No Allergies to PPS

10) No other potential safety jepordising events (eg respiratory/heart/etc etc problems)



SO, you can see it was a very deliberate selection. For Phase 3 it may be different in that they may actually want some of these groups to be deliberately included to test out these previously excluded patients. They may divvy the groups up as the whole point of 3rd phase is to test for safety at scale. If iPPS is show to have AE's for anyone that has heart problems in the past or are older than 70 then this must be found out, may not be a show stopper but further investigation/testing and perhaps if its not lethal then approritae warnings would need to be considered based on the rest of the results for the rest of the Trial 3 patient population.

- Mozz