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Posted On: 09/10/2020 6:14:29 PM
Post# of 148936
I have to agree... you don’t delay notice of an additional phase 3 hoop to jump through and not have another path intended instead of that phase 3 hoop. I believe this time was just a fast review of our HIV safety profile before approval for Covid Mild to Moderate in both the US and the UK. The UK has been reviewing our safety profile on our HIV BLA for a month or longer. I believe the FDA also has been reviewing our data even though the guidelines to not review our safety for HIV BLA submission came with denial of submission that was was given to Cytodyn.
These are extraordinary times where you don’t stop reviewing a drug that could save literally thousands upon thousands of lives. Reduce medical needs in hospitals across the world. Just because some guideline said so. It all makes sense to me. The FDA and OWS and the MHRA have been inquiring as to what help they can provide to line up all the ducks necessary to launch this life saving drug. It’s whirlwind time...
If this isn’t the way it really is happening. My bubble will burst. I can only hope that the good people of these regulatory agencies want to see the world back to some kind of normality.
Even though we will never see normal as we once new it. Hopefully some day in that 4-5 year average for vaccines we actually find a way to have a successful vaccine. I hope that returns us back to the normal we once had. I just don’t believe politics over science and a vaccine before that 4-5 year average scares me. Thankfully I will soon be able to avoid a major case of Covid if that were to happen. I am thankful to know about Leronlimab and soon the rest of the world will know. Even the Adam F’s and Adam L’s of the world who I have very much disdain for. Mainly for delaying this approval process even more for all the shorting of this company and for scaring away investors with all the false information and dirty rotten opinions. That totally let Cytodyn fly under the radar.
I think it is finally our time! Please let it be so!
GLTU
These are extraordinary times where you don’t stop reviewing a drug that could save literally thousands upon thousands of lives. Reduce medical needs in hospitals across the world. Just because some guideline said so. It all makes sense to me. The FDA and OWS and the MHRA have been inquiring as to what help they can provide to line up all the ducks necessary to launch this life saving drug. It’s whirlwind time...
If this isn’t the way it really is happening. My bubble will burst. I can only hope that the good people of these regulatory agencies want to see the world back to some kind of normality.
Even though we will never see normal as we once new it. Hopefully some day in that 4-5 year average for vaccines we actually find a way to have a successful vaccine. I hope that returns us back to the normal we once had. I just don’t believe politics over science and a vaccine before that 4-5 year average scares me. Thankfully I will soon be able to avoid a major case of Covid if that were to happen. I am thankful to know about Leronlimab and soon the rest of the world will know. Even the Adam F’s and Adam L’s of the world who I have very much disdain for. Mainly for delaying this approval process even more for all the shorting of this company and for scaring away investors with all the false information and dirty rotten opinions. That totally let Cytodyn fly under the radar.
I think it is finally our time! Please let it be so!
GLTU
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