SAF: 1. A biotech does not need to have an appr
Post# of 155128
(Total Views: 588)
Posted On: 08/27/2020 2:23:53 PM
SAF:
1. A biotech does not need to have an approved drug to be listed on the Nasdaq. Your argument that it is a requirement is factually incorrect (ok, A lie), otherwise the application would not have been entertained.
2. The FDA decision September 4, as you well know, is for a response to the RTF letter for the BLA. Due to FDA interference in the combination trials and mandate to increase dosing from 350 to 750 mg, HIV approval will not happen this year. Thank you for the reminder.
3. Enrollment of 195 patients (halfway to trial population of 390), has been reached, with interim analysis once that populations has reached 28 days, +/- September 22 plus time for analysis.
4. Fuerstein et all will likely continue to spew, as that is the only trick of the one trick pony. All that will matter is those who are dissuaded from participating in trials and succumb to Covid due to unwarranted doubt and the continued diversion of resources away from Leronlimab, a clinically demonstrated, effective therapeutic.
Perhaps you don't believe these matters, but I do.
I love my friends and family.
I care about my neighbors, fellow Americans and fellow humans on this planet.
I will never countenance the selfish behaviors that are diametrically opposed to the preservation of human life.
1. A biotech does not need to have an approved drug to be listed on the Nasdaq. Your argument that it is a requirement is factually incorrect (ok, A lie), otherwise the application would not have been entertained.
2. The FDA decision September 4, as you well know, is for a response to the RTF letter for the BLA. Due to FDA interference in the combination trials and mandate to increase dosing from 350 to 750 mg, HIV approval will not happen this year. Thank you for the reminder.
3. Enrollment of 195 patients (halfway to trial population of 390), has been reached, with interim analysis once that populations has reached 28 days, +/- September 22 plus time for analysis.
4. Fuerstein et all will likely continue to spew, as that is the only trick of the one trick pony. All that will matter is those who are dissuaded from participating in trials and succumb to Covid due to unwarranted doubt and the continued diversion of resources away from Leronlimab, a clinically demonstrated, effective therapeutic.
Perhaps you don't believe these matters, but I do.
I love my friends and family.
I care about my neighbors, fellow Americans and fellow humans on this planet.
I will never countenance the selfish behaviors that are diametrically opposed to the preservation of human life.
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