Here's a copy and paste post from the swamp by a seldom heard from poster, whom I believe to be genuine.
Deal Modeling by Clinical Trial Phase
I want to relay some information regarding big pharma deal modeling that may open some eyes and also help clarify IPIX's stance on waiting until Phase 2 results are known before entering a partnership agreement.
Modeling new pharmaceuticals involve risk assessments know as PTS (Probability of Technical Success; i.e. clinical trials meeting their endpoints) and PRS (Probability of Regulatory Success, likelihood of a health authority providing approval given a successful phase 3 in the target market). The formula for PTRS (Probability of Technical and Regulatory Success, so a combination of the two factors) = PTS of current phase x PTS of each subsequent phase x PRS. For example, the probability of success for an ongoing phase two study is the PTS of Phase 2 x PTS of Phase 3 x PRS.
Now, moving to real numbers, big pharma usually puts Phase 1 success about 50-60%, Phase 2 20-25%, Phase 3 50-65%, and PRS 75-90% depending on the individual molecule (type of drug, market identified to enter, etc. all have a factor and may make the % drastically different). The numbers I provided are the general guidelines. If you do the math on this it shows how impressive it would be if IPIX succeeds in their remaining Phase 2 trials given the success of the prior ones.
Looking back at my numbers, an ongoing Phase 2 study is only expected to be successful 1 out 4 or 5 times at 20-25%. The overall expected success (PTS) of an ongoing phase 2 study would be 20% (Phase 2 PTS) x 60% (Phase 3 PTS) = 12%. Multiply this by even a 90% PRS and you come to a 10.8% chance of success (approval by the health authority). This is how pharma deal models look at this stage; however, if we achieve a successful phase 2, that PTS = 100%. Probability of approval now moves to 60% (Phase 3 PTS) x 90% (PRS, likelihood of approval by health authority given successful Phase 3) = 54%.
To summarize, deal modeling an ongoing phase 2 assumes approval is achieved only 10.8%. With a successful Phase 2 (trial endpoints met), this expectation jump 5 times to 54%. This illustrates Dr. B's insistence on only partnering after Phase 2 and also demonstrates what an amazing accomplishment it would be to have several successful Phase 2 results.
Again, each case will be evaluated individually and alter these numbers.
In the wake of no news we get so focused on what the problem is, but there are several very complicated factors in play. For IPIX they have multiple Phase 2's for the same drug for different indications. This obviously complicates making a deal for Brilacidin that has been expressed several times by other individuals here. For Prurisol it's less complicated as the indication is straight forward. K is still too early and I also assume a cancer drug will lower the assumed PTS in any deal model. For an ongoing phase 2 of a cancer treatment I would imagine the PTRS assumed in deal modeling is less than the 10.8% general guideline.
I wanted to draw the conversation back to a more macro level rather than the pin-point focus on IPIX and its management. Striking a deal is a very complicated process and the PTRS is just one piece of it, but I believe the odds shown here helps explain the "delay"/disappointment over the lack of a deal so far, but also help show the opportunity IPIX presents if it can continue its track record of success in clinical trials. I'm still holding because I believe the science has proven extremely impressive, but I will obviously reassess over the next few months as results are known.
Thank you to those who actually make informed, thought-provoking posts meant to spur discussion in either direction, contemplating why IPIX may succeed or even fail, rather than simply posting unsubstantiated enthusiasm or fear mongering.
Deal Modeling by Clinical Trial Phase
I want to relay some information regarding big pharma deal modeling that may open some eyes and also help clarify IPIX's stance on waiting until Phase 2 results are known before entering a partnership agreement.
Modeling new pharmaceuticals involve risk assessments know as PTS (Probability of Technical Success; i.e. clinical trials meeting their endpoints) and PRS (Probability of Regulatory Success, likelihood of a health authority providing approval given a successful phase 3 in the target market). The formula for PTRS (Probability of Technical and Regulatory Success, so a combination of the two factors) = PTS of current phase x PTS of each subsequent phase x PRS. For example, the probability of success for an ongoing phase two study is the PTS of Phase 2 x PTS of Phase 3 x PRS.
Now, moving to real numbers, big pharma usually puts Phase 1 success about 50-60%, Phase 2 20-25%, Phase 3 50-65%, and PRS 75-90% depending on the individual molecule (type of drug, market identified to enter, etc. all have a factor and may make the % drastically different). The numbers I provided are the general guidelines. If you do the math on this it shows how impressive it would be if IPIX succeeds in their remaining Phase 2 trials given the success of the prior ones.
Looking back at my numbers, an ongoing Phase 2 study is only expected to be successful 1 out 4 or 5 times at 20-25%. The overall expected success (PTS) of an ongoing phase 2 study would be 20% (Phase 2 PTS) x 60% (Phase 3 PTS) = 12%. Multiply this by even a 90% PRS and you come to a 10.8% chance of success (approval by the health authority). This is how pharma deal models look at this stage; however, if we achieve a successful phase 2, that PTS = 100%. Probability of approval now moves to 60% (Phase 3 PTS) x 90% (PRS, likelihood of approval by health authority given successful Phase 3) = 54%.
To summarize, deal modeling an ongoing phase 2 assumes approval is achieved only 10.8%. With a successful Phase 2 (trial endpoints met), this expectation jump 5 times to 54%. This illustrates Dr. B's insistence on only partnering after Phase 2 and also demonstrates what an amazing accomplishment it would be to have several successful Phase 2 results.
Again, each case will be evaluated individually and alter these numbers.
In the wake of no news we get so focused on what the problem is, but there are several very complicated factors in play. For IPIX they have multiple Phase 2's for the same drug for different indications. This obviously complicates making a deal for Brilacidin that has been expressed several times by other individuals here. For Prurisol it's less complicated as the indication is straight forward. K is still too early and I also assume a cancer drug will lower the assumed PTS in any deal model. For an ongoing phase 2 of a cancer treatment I would imagine the PTRS assumed in deal modeling is less than the 10.8% general guideline.
I wanted to draw the conversation back to a more macro level rather than the pin-point focus on IPIX and its management. Striking a deal is a very complicated process and the PTRS is just one piece of it, but I believe the odds shown here helps explain the "delay"/disappointment over the lack of a deal so far, but also help show the opportunity IPIX presents if it can continue its track record of success in clinical trials. I'm still holding because I believe the science has proven extremely impressive, but I will obviously reassess over the next few months as results are known.
Thank you to those who actually make informed, thought-provoking posts meant to spur discussion in either direction, contemplating why IPIX may succeed or even fail, rather than simply posting unsubstantiated enthusiasm or fear mongering.
5
Innovation Pharmaceuticals Inc (IPIX) Stock Research Links
Lord, help me to be the person that my dogs think I am...
