Somber day… Can’t find the love for the FDA fo
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Posted On: 02/23/2022 12:13:06 AM
Somber day… Can’t find the love for the FDA for their petty letters. It is what it is. We all knew Nader operated on the edge with predictions and such. Maybe the FDA didn’t listen to the disclaimer at the beginning of each PR or conference call? Seems a little tight in their view of thing said. Can’t change our history now and having 20/20 hindsight will not help us. So we move on…
I feel the first news we will get is when we hire a new CEO. A material event. Then the CEO will give us his/her plan for our company just like he/she has for the BOD to be selected to run this company. I am sure the future CEO will have researched our possibilities and have a good handle on everything we need and the proper direction to start and to find our way to our first approval of any kind. If he/she hasn’t already been successful before in drug approvals then is this the person who we should hire? I hope the BOD holds out for an experienced CEO. We need to hold out for someone that has been there and done that. Knows how to get us over the finish line. Has the ability to turn a biotech into a pharmaceutical company. That’s the dream or my dream anyway.
You guys can hope for a NDA or quite period but reality is we need leadership and a new CEO is the first thing we need. I am not on the level of a partnership. Hell… I could be way wrong there but… Hopefully a new CEO shortly after being hired to lead CYDY this CEO will show us the future direction or his/her plan. Tell us where we are and what our focus will be. Then probably tell us we will not have PR’s unless it’s a material event. This is what I feel is happening right now. No news worthy we are not going to hear anything anymore.
There clearly needs to be a change in how this company is going to be run to satisfy the powers of the FDA and we all are just going to have to suck it up. Ween ourselves off the PR’s and get use to real important news only or material events only. The flippers and the shorts will get no information and will take hits from out of the blue if they try to short CYDY. I suspect this could be our new path with new leadership. We will no longer be in the top ten traded OTC stocks this year. This is my prediction… I could be wrong… who knows right?
I base my prediction on Big Pharma hesitancy to partner or buy out biotechs that don’t have a minimum of one approval and some deals are struck only after two approvals of some kind. They usually don’t include filed BTD’s but Dr. Kelly thought so. I bet he meant accepted BTD’s. To many Big Pharma’s have been burned the past few years on big expensive buy outs and not been able to get the drug(s) approved. Yes… even they fail to get BLA’s approved. We or CYDY doesn’t have one approval yet and just don’t quite meet the prerequisite that Big Pharma has been mostly setting the bar at the past few years. They do say there is lots of extra money made from this pandemic… I am sure there are exceptions and there could be some kind of negotiation going on right now. Do you think todays news helped if there was a negotiation happening?
Any way you look at it. We have not been lied to in my opinion. We have a very possible multi-platform drug that needs a lot of help filing for approvals. Might need a few more trials for some. I am in this for the long run and won’t back out now. I feel we are still looking at good times. Only time will tell. This is my chosen direction.
This is not investment advice for anyone. Do your own D&D and know what you own and make your own plan. The sun will shine on us all… is my hope.
GLTUA…
I feel the first news we will get is when we hire a new CEO. A material event. Then the CEO will give us his/her plan for our company just like he/she has for the BOD to be selected to run this company. I am sure the future CEO will have researched our possibilities and have a good handle on everything we need and the proper direction to start and to find our way to our first approval of any kind. If he/she hasn’t already been successful before in drug approvals then is this the person who we should hire? I hope the BOD holds out for an experienced CEO. We need to hold out for someone that has been there and done that. Knows how to get us over the finish line. Has the ability to turn a biotech into a pharmaceutical company. That’s the dream or my dream anyway.
You guys can hope for a NDA or quite period but reality is we need leadership and a new CEO is the first thing we need. I am not on the level of a partnership. Hell… I could be way wrong there but… Hopefully a new CEO shortly after being hired to lead CYDY this CEO will show us the future direction or his/her plan. Tell us where we are and what our focus will be. Then probably tell us we will not have PR’s unless it’s a material event. This is what I feel is happening right now. No news worthy we are not going to hear anything anymore.
There clearly needs to be a change in how this company is going to be run to satisfy the powers of the FDA and we all are just going to have to suck it up. Ween ourselves off the PR’s and get use to real important news only or material events only. The flippers and the shorts will get no information and will take hits from out of the blue if they try to short CYDY. I suspect this could be our new path with new leadership. We will no longer be in the top ten traded OTC stocks this year. This is my prediction… I could be wrong… who knows right?
I base my prediction on Big Pharma hesitancy to partner or buy out biotechs that don’t have a minimum of one approval and some deals are struck only after two approvals of some kind. They usually don’t include filed BTD’s but Dr. Kelly thought so. I bet he meant accepted BTD’s. To many Big Pharma’s have been burned the past few years on big expensive buy outs and not been able to get the drug(s) approved. Yes… even they fail to get BLA’s approved. We or CYDY doesn’t have one approval yet and just don’t quite meet the prerequisite that Big Pharma has been mostly setting the bar at the past few years. They do say there is lots of extra money made from this pandemic… I am sure there are exceptions and there could be some kind of negotiation going on right now. Do you think todays news helped if there was a negotiation happening?
Any way you look at it. We have not been lied to in my opinion. We have a very possible multi-platform drug that needs a lot of help filing for approvals. Might need a few more trials for some. I am in this for the long run and won’t back out now. I feel we are still looking at good times. Only time will tell. This is my chosen direction.
This is not investment advice for anyone. Do your own D&D and know what you own and make your own plan. The sun will shine on us all… is my hope.
GLTUA…
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