OTCnewbie, You bring two good points: 1) We
Post# of 153822
(Total Views: 1118)
Posted On: 08/03/2020 7:36:56 AM
OTCnewbie,
You bring two good points:
1) We need to keep our feet to the ground: We have a P2 that will likely (well, that already) show benefit as depicted by SAE's and NEWS2 results. This dos not mean we will have a day 14 statistical results and/or that FDA will say" OK, OK we will approve and you can sell.
No, we have a long road ahead. FDA can easily say: well done !!, let's start with P3. And yes, positive results will open venues and stock price appreciation.
We have a P3 close to DSMB review for severe/critical. This is a more clear-cut, and, in my opinion, we have a better option as there is less competition and is "easier" to probe if our drug works.
And here comes the "timing" fact: will CD12 reinforce CD10 (granted the results are good)??? imo if done properly, yes. And in observing CYDY I believe this has been in NP's mind all the time. CYDY has control over the "length" of te time it takes by AMAREX to "complete the study" in order to wait for some CD12 results in such a way that the FDA is presented with a double whammy in a way that it can not avoid to be hit on the chin.
Both CD10 and CD12 will then favorably reinforce each other.
And then, the second point:
What do we do then ??? If the priority is to save lives (put Leronlimab in the market with proper volume and quick, like yesterday) , we need either to receive help from the government (as NP mentioned in one interview) or partner. I would prefer the former, however I have doubts it will be forthcoming. We are NOT BP.
The fact is, lots of money and a ramp-up of production will be necessary. Your point of a partnership (for COVID only) would be an appropriate route. Perhaps detrimental for our bottom line but, remember, the idea is to save lives (mostly I the USA as basically the virus is rampant and government has effectively given up in trying to control it).
Am I bringing the cart before the horse ? probably, but heck is Monday, we are in August and I am feeling optimistic
.
You bring two good points:
1) We need to keep our feet to the ground: We have a P2 that will likely (well, that already) show benefit as depicted by SAE's and NEWS2 results. This dos not mean we will have a day 14 statistical results and/or that FDA will say" OK, OK we will approve and you can sell.
No, we have a long road ahead. FDA can easily say: well done !!, let's start with P3. And yes, positive results will open venues and stock price appreciation.
We have a P3 close to DSMB review for severe/critical. This is a more clear-cut, and, in my opinion, we have a better option as there is less competition and is "easier" to probe if our drug works.
And here comes the "timing" fact: will CD12 reinforce CD10 (granted the results are good)??? imo if done properly, yes. And in observing CYDY I believe this has been in NP's mind all the time. CYDY has control over the "length" of te time it takes by AMAREX to "complete the study" in order to wait for some CD12 results in such a way that the FDA is presented with a double whammy in a way that it can not avoid to be hit on the chin.
Both CD10 and CD12 will then favorably reinforce each other.
And then, the second point:
What do we do then ??? If the priority is to save lives (put Leronlimab in the market with proper volume and quick, like yesterday) , we need either to receive help from the government (as NP mentioned in one interview) or partner. I would prefer the former, however I have doubts it will be forthcoming. We are NOT BP.
The fact is, lots of money and a ramp-up of production will be necessary. Your point of a partnership (for COVID only) would be an appropriate route. Perhaps detrimental for our bottom line but, remember, the idea is to save lives (mostly I the USA as basically the virus is rampant and government has effectively given up in trying to control it).
Am I bringing the cart before the horse ? probably, but heck is Monday, we are in August and I am feeling optimistic
.
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