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Posted On: 03/10/2020 5:07:26 PM
Post# of 145903
While I agree that we need to get to market as quickly as possible - and I doubt that anyone disagrees with that - the odds of another company essentially starting from scratch and beating CytoDyn to the punch with another CCR5 inhibitor are astronomically small at this point. First, to the best of our knowledge, we're weeks away from filing a completed BLA, and we have several P2 trials in the works for other indications. We were allowed to skip P1 trials due to the fact that safety is already well demonstrated. Historically, safety data has not been so kind to CCR5 inhibitors, and I strongly doubt that the FDA would allow anything to be significantly fast tracked based on that knowledge. The only other CCR5 inhibitors anywhere near the market are maraviroc and cenicriviroc, and both have shown serious toxicity issues. Not to mention, efficacy appears significantly higher (at least for HIV, where we have relatively apples to apples data) for leronlimab.
In short, any other company - no matter how well funded - would be many years from a finished product. CytoDyn is weeks away from filing the BLA for HIV and hopefully getting to market relatively shortly thereafter, and who knows how BTD could play out for cancer with the results we've seen so far. Even if another company got one to market relatively soon after that, they'd have to produce something better than nearly perfectly safe and (apparently) highly effective. I'm much more concerned about being hit by a meteor.
In short, any other company - no matter how well funded - would be many years from a finished product. CytoDyn is weeks away from filing the BLA for HIV and hopefully getting to market relatively shortly thereafter, and who knows how BTD could play out for cancer with the results we've seen so far. Even if another company got one to market relatively soon after that, they'd have to produce something better than nearly perfectly safe and (apparently) highly effective. I'm much more concerned about being hit by a meteor.
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