In regard to RP11, over the coming months the landscape may significantly change in terms of what thresholds a business deal may look like. We already know that there are a 'number' of interested parties and that PYC has previously released updates highlighting terrific early safety data combined with very good early efficacy data, which has no doubt been a major factor, (amongst quite a few other reasons), for the current level of engagement and appetite for a BD on RP11.
PotentialInflection #1 (next 10 days, maybe a little less)
We are on the cusp of 'next level' data info coming from the ongoing SAD/MAD extension study for RP11. RH has himself described the data thus far as very good, and that the Company is keen for this to upgraded to excellent based on potential clinical results possibly from extended data coming through. We won't know if will achieve excellence until we do, however we will probably know very soon and that will no doubt change how potential partners may calibrate the value of PYC's RP11 program in terms of chance of success and what they may feel is a good enough deal to get a seat at the PYC table.
Potential Inflection #2 (6 - 7 weeks)
Contingent that PYC notches up the above outcome, for clinically excellent extended data for both safety and efficacy, then that exponentially enhances our chances for an Accelerated, combined P2/P3 registrational trial for RP11. In early June, PYC is expected to be meeting with the FDA to gain clarity on this matter. This begs the question, will one of those interested BD parties be keen enough to put up a knockout bid at this point? Maybe or maybe not, however in theory it is possible but I think PYC may wish to wait a little longer...
Potential Inflection #3
This is where things are most likely to really start getting hot!
Contingent with the opportunity that the FDA is of the conviction that PYC have what it takes to submit an application for an accelerated P2/P3 registrational trial, then PYC will need to go through the submission process and await official acceptance, (or not). With a FDA accelerated approval under our belt is when I believe the pressure will truly be felt amongst those interested parties to put up their best deal, otherwise they would almost certainly risk missing out all together.
For PYC, in the lead up as well as during ongoing progression from point to point, the Company needs to focus 100% on exquisitely executing all elements pertaining to the RP11 program. RH has already commented with words that reflects that mindset, I have every confidence that PYC will be giving it their best shot and that best shot will reflect a model of excellence. I am not sure exactly how long all this will take to play out however it certainly has the potential to be a gamechanger for RP11 and with how the market may value PYC's pipeline overall... not forgetting that PKD is moving rapidly as well.
Best wishes to all
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In regard to RP11, over the coming months the landscape may...
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