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Sunday, September 02, 2018 3:43:34 PM
"More important and of concern is the fact that numbness and tingling are still extremely frequent AEs (58-74%) in the Phase 2b trial despite the dose reduction. The syndrome has been described as “paresthesias, usually beginning in the oral area, and often with subsequent extension to one or more of the following areas: face, scalp, extremities, upper thorax, and/or perineum (groin and buttocks)”; the company refers to it as an ‘ion channel effect’ of short duration and reversible.[3]"
Obviously the paragraph, in referring to the Phase 2B trial is talking about the CTIX trial, UNLESS that's a typo and I'm beginning to think that it was (Geez Louise, what a place for typo!). I had heard of the tingling issue but it was downplayed as insignificant (as one might expect in these parts). BUT I just now noticed that within the paragraph it says "the company refers to it as an ‘ion channel effect’" and when one Googles that phrase it is attributed to Polymedix a number of times with the only use of it associated with Cellceutix occurring in THIS article. I don't think that Cellceutix used the phrase. Adding to my initial belief was the phrase "despite the dose reduction", which I know occurred in the CTIX trial.
Someone is confused. I'm ALWAYS confused but this time I think I have company. I would have thought that "extremely frequent AEs (58-74%)" would have been mentioned by this Company or someone here and I did not recall that happening.
2. "Rosen law firm gives an estimate of $100M in their class action suit."
Rosen is nuts and I rarely use him as a reference.
That said I believe the $30M estimate was well sourced. I also believe that it didn't reflect any benefits that would have been gained from the up front guidance provided by a SPA agreement. I'm also not sure that the other QIDP benefits were considered:
"Incentives available to sponsors of QIDP include fast track designation, priority review designation, and 5 years of additional market exclusivity. “Additional” is the key operative word. Exclusivity under the GAIN provisions adds 5 years of additional market exclusivity under certain circumstances to drugs with the QIDP designation and that are eligible for another type of exclusivity."
https://camargopharma.com/2018/01/505b2-qidp-designation-8-years-exclusivity/
But can it core A apple?
Yes Ralph, of course it can core A apple.
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