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threebabiesbusy

05/12/23 8:30 AM

#35656 RE: Classic Warrior #35655

The DSMB recommended that the Study be halted early due to statistical significance of the primary endpoint likely not going to be met should the Study continue towards completion. Based on the recommendation from the DSMB, the Company has halted the Study and will now proceed to unblind and seek an evaluation of the Study’s data, including the COVID-19 clinical symptoms data (i.e. cough, fever, heart rate, and oxygen saturation) to determine the potential next clinical and regulatory steps for Bucillamine.
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tripmcneely

05/12/23 8:54 AM

#35657 RE: Classic Warrior #35655

“The Company believes that once it has completed the evaluation of the Study’s data, it could support further discussions with the FDA on potential new clinical studies and allow the opportunity to work with potential domestic and international pharmaceutical partners to determine a suitable regulatory pathway for approval of Bucillamine based on the evaluated Study’s data.”


This study is done and a wash apparently. Only way forward is a partner and new clinical trials for a “suitable regulatory pathway” which we all know how long will take. The fat lady has sung. How low does it go today? .2? .1? 0?
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Rubberneck2

05/12/23 9:50 AM

#35667 RE: Classic Warrior #35655

The fly sucks. It should have said something. Where's the swatter?
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Gatorca

05/12/23 2:08 PM

#35685 RE: Classic Warrior #35655



Ps. Guess we will see...

Pps. Oh chit the boss is coming, back to work