Slcimmuno's reply is excellent also.
Wednesday, 05/10/17 02:25:18 PM
Re: faraifarai post# 181476
Bravo. Been quite a quite a while since I posted – busy with life happens stuff. But wanted to chime in though and second your spot-on post, along with the comments by a few others who’ve been Fighting the Good Fight against FUD, or the cry babies who whine and whine and whine… instead of just cutting bait and moving on. (Gosh how this Board has changed… imho for the worse.) The science with CTIX has always been strong and now we’re only months away from possibly-to-probably realizing the rewards.
The signal being sent by CTIX management couldn’t be more obvious. They think they have the goods that Big Rx is interested in, with at least some reviewing P or B or K (maybe even all three) under CDA. Prurisol has the potential to match and maybe even beat the likes of Otezla… ~30% PASI 75 (at 16 wks, not 12 wks one should note) is not all that high of a bar. The Phase 2 PsO trial, under the IGA scale, showed 50% of patients achieved an IGA score of 1 (almost clear) or O (clear), with 46% of patients with moderate psoriasis meeting the primary efficacy endpoint (a 2-pt drop). Admittedly, it was smaller trial but that’s why they do the trials, as they say. And the Phase 2b is exactly that—sufficiently powered to see if the signal, indeed, was true. I’m betting significant coin that it is. And if P encroaches into biologics terrain, say, 40-50% PASI 75, with PASI 90s and PASI 100s—all within 12 weeks. Well, then, the bidding (“Go Shop” clause fun) would really begin. As to Brilacidin, my personal fave (long live DeGrado and Klein and other members of Polymedix scientific brain trust), the interim results for IBD and OM have been outstanding. Some may have wanted management to pursue ABSSSI but I think it was the right move to go after the anti-inflammatory indications, not the antibacterial ones ($30m saved, with funds better spent elsewhere). Brilacidin truly has platform potential. People laugh at references to Humira but I think B’s breadth/reach is just being scratched…. As in eczema, h suppurative, acne (Derm) as well as UC, Crohn’s. Plus we already have ABSSSI in a P2b bag. And then there is K—having been a bit lost but not forgotten. The P2 OC trial should serve to more fully inform the MOA (though the MOAs of lots of drugs are sometimes never known) and may even result in positive outcomes (per RECIST criteria). And if that oral formulation comes thru, then even better, given the PD (short half-life of K). I remember way back when, when I donned the CTIX research cap for the IHUB board, a leading p53 researcher sayin that “The first p53 to make it to market will change the world.” Indeed. And Kevetrin is one of the few still in human trials—its safety profile proving boon not bane (See JUNO/KITE struggles as reference).
So: I say hold the line Longs. Continue to Fight the Good Fight against FUD. The last 2 years have been hard to take, but not as much if you train your gaze on what ultimately will matter most: The Science. Sufficient funds are in place to see us through to the finish line. While there are no guarantees, particularly in biotech, I very much like the odds and am putting my $ where my mind is.
Wednesday, 05/10/17 02:25:18 PM
Re: faraifarai post# 181476
Bravo. Been quite a quite a while since I posted – busy with life happens stuff. But wanted to chime in though and second your spot-on post, along with the comments by a few others who’ve been Fighting the Good Fight against FUD, or the cry babies who whine and whine and whine… instead of just cutting bait and moving on. (Gosh how this Board has changed… imho for the worse.) The science with CTIX has always been strong and now we’re only months away from possibly-to-probably realizing the rewards.
The signal being sent by CTIX management couldn’t be more obvious. They think they have the goods that Big Rx is interested in, with at least some reviewing P or B or K (maybe even all three) under CDA. Prurisol has the potential to match and maybe even beat the likes of Otezla… ~30% PASI 75 (at 16 wks, not 12 wks one should note) is not all that high of a bar. The Phase 2 PsO trial, under the IGA scale, showed 50% of patients achieved an IGA score of 1 (almost clear) or O (clear), with 46% of patients with moderate psoriasis meeting the primary efficacy endpoint (a 2-pt drop). Admittedly, it was smaller trial but that’s why they do the trials, as they say. And the Phase 2b is exactly that—sufficiently powered to see if the signal, indeed, was true. I’m betting significant coin that it is. And if P encroaches into biologics terrain, say, 40-50% PASI 75, with PASI 90s and PASI 100s—all within 12 weeks. Well, then, the bidding (“Go Shop” clause fun) would really begin. As to Brilacidin, my personal fave (long live DeGrado and Klein and other members of Polymedix scientific brain trust), the interim results for IBD and OM have been outstanding. Some may have wanted management to pursue ABSSSI but I think it was the right move to go after the anti-inflammatory indications, not the antibacterial ones ($30m saved, with funds better spent elsewhere). Brilacidin truly has platform potential. People laugh at references to Humira but I think B’s breadth/reach is just being scratched…. As in eczema, h suppurative, acne (Derm) as well as UC, Crohn’s. Plus we already have ABSSSI in a P2b bag. And then there is K—having been a bit lost but not forgotten. The P2 OC trial should serve to more fully inform the MOA (though the MOAs of lots of drugs are sometimes never known) and may even result in positive outcomes (per RECIST criteria). And if that oral formulation comes thru, then even better, given the PD (short half-life of K). I remember way back when, when I donned the CTIX research cap for the IHUB board, a leading p53 researcher sayin that “The first p53 to make it to market will change the world.” Indeed. And Kevetrin is one of the few still in human trials—its safety profile proving boon not bane (See JUNO/KITE struggles as reference).
So: I say hold the line Longs. Continue to Fight the Good Fight against FUD. The last 2 years have been hard to take, but not as much if you train your gaze on what ultimately will matter most: The Science. Sufficient funds are in place to see us through to the finish line. While there are no guarantees, particularly in biotech, I very much like the odds and am putting my $ where my mind is.
4
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