Absolutely insane? Whats absolutely insane is for shareholders to complain about inaction of our management when they have continually posted trial designs and results of just the opposite. Its been posted multiple times the average it takes a drug to make it to market. These averages do not include trials “surviving” a pandemic, which some company trials did not.
All this being said timelines understandably get pushed back but I take the leadership for their word. Their goal has always been to get this drug to market as fast as safely, insureably, and broadly (hence safety, adult, and pediatric) to market. Who knows better first hand than Dr. Missling or Dr. Walter Kauffman how these patients suffer? To think they are playing games or are inept given the conditions and timelines if ignorant. This self inflicted Rett awareness month deadline is just that a set up for failure by those that “wished” it to be true. Instead, shareholders should rely more on communications coming from management with an understanding that there are delays, strategic corporate plans, patents, and other factors at play. I also believe that in “getting this right”, in both RS and AD they are laying groundwork for future trials. Everyone here is so “one trick pony” in their assessment of trial timelines….. these trials imo have major implications for the very near future starting of trials.
So no, receiving TLD results from a culmination of 3 RS trials, proving without a doubt, efficacy leading to an NDA for SOC for RS is not insane. Also as others have pointed out this will be a validation of our MOA and lead to further rare disease approvals like a “string of inestimable pearls”. To support/justify in part this belief we have heard from management that there has been unsolicited partnership talks.
Patience grasshopper
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