Well… what now? We always knew that we were going to be an oncology company. Is anybody really surprised? Looks like that might be our first approval. Since we missed by what? Six months of another company submitting new data and being approved before us on mTNBC. Setting the bar high enough that we just missed a quick approval even though we had better data but not enough to get break through approval.
Back to the drawing board in cancer and actually do a proper phase 3 trial on mTNBC. One with more than 28 patients from 3 different trials for not so good data but enough to really get excited about.
A properly designed trial with a proper CRO could be a boon for us all. We know that mTNBC is pretty much a lock with proper designed trial and good data and enough patients like 100 or so. But other cancer treatments as a whole could be some angles for Leronlimab too. Exploring some of those before trying the very expensive NASH needed trials is my preference unless we do another cheaper phase 2 confirmation trial showing that NASH is in our wheel house and just a partner is needed to push the expensive trial we all know we need.
No matter what happens Monday the shorts like Craig won’t take the stock price down to much. The potential was never great for revenue from HIV being just a small HIV sub population we were shooting for. We can still shoot for NIH HIV cure monies to keep Dr. Sasha busy. Other HIV indications for long term use of 2 or 3 months between doses is probably to late to get in the game and will the FDA allow us that space if we show we excel in that area?
The FDA probably won’t allow us to compete for those patients. This is what bothers me about a capitalist limiting FDA. Novavax proven safe and with great efficacy. They only allowed them a market that wouldn’t make them much money on sales. The were only approved for people that have not taken any vaccines for Covid. Being a traditional style vaccine instead of new mRNA. They cut their ability to make sales in the USA and cut their value by 66% over a month after a FDA EUA approval. The like approvals around the world put no such limitations on Novavax like this. Why did the FDA? Is it a stacked deck we are always playing against? It sure looks like it. But onward and upward. I will still stay invested in CYDY because Leronlimab is a gem and some day it will break through and impress those that will listen and give it the proper acknowledgment. I still believe or as Journey ‘s song says… keep on believing!
Back to the drawing board in cancer and actually do a proper phase 3 trial on mTNBC. One with more than 28 patients from 3 different trials for not so good data but enough to really get excited about.
A properly designed trial with a proper CRO could be a boon for us all. We know that mTNBC is pretty much a lock with proper designed trial and good data and enough patients like 100 or so. But other cancer treatments as a whole could be some angles for Leronlimab too. Exploring some of those before trying the very expensive NASH needed trials is my preference unless we do another cheaper phase 2 confirmation trial showing that NASH is in our wheel house and just a partner is needed to push the expensive trial we all know we need.
No matter what happens Monday the shorts like Craig won’t take the stock price down to much. The potential was never great for revenue from HIV being just a small HIV sub population we were shooting for. We can still shoot for NIH HIV cure monies to keep Dr. Sasha busy. Other HIV indications for long term use of 2 or 3 months between doses is probably to late to get in the game and will the FDA allow us that space if we show we excel in that area?
The FDA probably won’t allow us to compete for those patients. This is what bothers me about a capitalist limiting FDA. Novavax proven safe and with great efficacy. They only allowed them a market that wouldn’t make them much money on sales. The were only approved for people that have not taken any vaccines for Covid. Being a traditional style vaccine instead of new mRNA. They cut their ability to make sales in the USA and cut their value by 66% over a month after a FDA EUA approval. The like approvals around the world put no such limitations on Novavax like this. Why did the FDA? Is it a stacked deck we are always playing against? It sure looks like it. But onward and upward. I will still stay invested in CYDY because Leronlimab is a gem and some day it will break through and impress those that will listen and give it the proper acknowledgment. I still believe or as Journey ‘s song says… keep on believing!
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