The FDA meeting now being in October makes sense w
Post# of 154867
(Total Views: 515)
Posted On: 08/16/2019 7:17:08 PM
The FDA meeting now being in October makes sense with the time of the Combo filing. If I had to guess, the FDA wants to see the whole combo package before giving CYDY its recommendations for the mono trail. I personally believe the FDA is excited about this drug, but obviously can’t express it.
The finance piece is just a wait and see game, kind of frustrating, as we are very much left in the dark, but at least things seem to be in our favor. I wouldn’t be surprised to hear of a deal in the next two months, maybe less, who knows. Also, if someone signs a deal with us in alignment with the BLA submission, it gives me a lot more confidence in the quality of the BLA and it’s likelihood of being accepted and eventually approved, not that I’m not confident now.
I believe a partnership will be what catapults the SP, all pending on the size of he upfront payment. This is more to say that clinical data isn’t doing it. It seems that management might want to limit the size/terms of the partnership if they feel they can go at it alone and preserve the value for a bigger buyout down the road, I would prefer this.
From the last interview NP mentioned not to expect results from breast cancer until after 4-5 CTC samples have been collected and analyzed (84-105+ days), also wouldn’t expect them to report results of just one patient. I don’t see tnbc moving the needle until mid November the earliest, but not far away at all.
My hope/prediction is 2.5x before Christmas, but tbh I wouldn’t be surprised to see several dollars if everything went our way in terms of milestones. I am still kind of blown away by the reality of this company, and its potential.
I’m curious in seeing the NASH and cancer preclinical results, do we have a timeframe for these?
The finance piece is just a wait and see game, kind of frustrating, as we are very much left in the dark, but at least things seem to be in our favor. I wouldn’t be surprised to hear of a deal in the next two months, maybe less, who knows. Also, if someone signs a deal with us in alignment with the BLA submission, it gives me a lot more confidence in the quality of the BLA and it’s likelihood of being accepted and eventually approved, not that I’m not confident now.
I believe a partnership will be what catapults the SP, all pending on the size of he upfront payment. This is more to say that clinical data isn’t doing it. It seems that management might want to limit the size/terms of the partnership if they feel they can go at it alone and preserve the value for a bigger buyout down the road, I would prefer this.
From the last interview NP mentioned not to expect results from breast cancer until after 4-5 CTC samples have been collected and analyzed (84-105+ days), also wouldn’t expect them to report results of just one patient. I don’t see tnbc moving the needle until mid November the earliest, but not far away at all.
My hope/prediction is 2.5x before Christmas, but tbh I wouldn’t be surprised to see several dollars if everything went our way in terms of milestones. I am still kind of blown away by the reality of this company, and its potential.
I’m curious in seeing the NASH and cancer preclinical results, do we have a timeframe for these?
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