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Just did, thanks.
It’s just not a time to make a change. In sports they generally wait until the season is over. Go Blazers.
Can somebody confirm a member of the 13-d group is an ex Gilead VP?
312 is now replacing 5.95.
Best post today
Check this out, he was talking about ENZC. At the beginning he says he works at Texas A&M.
Research Center
Enzolytics, Inc.
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-4478
SOURCE: Enzolytics, Inc.
Just sayin
Agree, I failed to mention this post was for HGEN trial. I am not sure of the RLFTF trial. Although both trials seem to have some skepticism following them.
The study didn't prove the drug reduces deaths, however. Among patients receiving lenzilumab, the death rate was 9.6%, compared with 13.9% in the placebo group. The difference wasn't statistically significant, though the company said the study wasn't designed primarily to demonstrate a reduction in deaths.
It’s a stupid post, another attack against Nader.
He literally said it could be 2 weeks. This is part of week 1. I am not sure what your point is.
“Doesn’t know Dic” classic ????
This is from Reddit user u/Upwithstock ;
EUA Debate
EUA's Debate!!
I have read some posts regarding EUA's and I thought I would clarify a few things points:I having been in the medical device space for 29 years and some of those years working closely with my regulatory colleagues to help them submit our FDA applications.
1) The FDA process for EUA's: Companies have to apply for the EUA. I have read comments like "the FDA rejected the EUA from CYDY". That is not the case. An 8K will be issued within the allowed window, that CYDY submitted an application for an EUA. This submission would be considered "material news" and CYDY has not revealed that yet!
2) FDA approvals and EUA's can be conditional. YES, in fact all approvals are at a minimum conditional because they involve labeling. The labeling contains the conditions/indications for use. Other conditional approvals or EUA's pre-specify exactly what conditions the FDA might impose. Many products get an approval and the condition is that the FDA still wants more data and requires the company to continue with a Post Market Study. The FDA has the ability to do that with Leronlimab, if CYDY could submit their CD12 data (Which FDA has already seen) and on CYDY's application. CYDY could state "we are requesting EUA for COVID Critical patients." The FDA could GRANT an EUA to CYDY for that indication with the condition that they also complete the CD16 140 patient trial.
On the conference call NP in his prepared remarks mentioned at the 5:52 time frame that an EUA could be submitted with CD12 data. But, we all know NP, later on during the Q&A session he was not as clear. In fact, he implied, an EUA submission for CD16 followed by the BLA and full approval.
3) EUA's and Full approval are different and they are not the same. However, they both allow the company to begin marketing/Selling the product under the conditions imposed in the EUA or Full Approval...and you should know that the FDA does not use the word "approval" they use the word "Clearance" . They "clear" a product for use, and then they name the indications/conditions.
Nonetheless, I hope that clarify's a couple of things regarding EUA's and I hope that TEAM CYDY feels that they could/should submit an application for an EUA using other data points that point towards COVID Critical patients.
I can feel it in the air tonight. Hold on hold on.
I think hearing directly from Mahoob in this situation is exactly what we need. I am not convinced we are aware of what the exact problem is. I don’t think NP wanted to go into it. Please post if somebody hears back. And thanks for sharing.
I agree, the bottom line is everybody knows the drug works now. Let that sink in. The little molecule is effective! Spread the word is what we can do.
They are blowing this up. Social media will be ablaze with all the pr’s and what’s happening. The world will want this now. I think it is absolutely brilliant. Just watch the show. Everybody knows it works. Nobody is saying it doesn’t. It’s just bullshit holding it down. Enjoy.
The media should get ahold of this story. Biden’s presidency does not want the dirty FDA messing up his coronavirus campaign. I agree with your post. We will get there but it’s disgusting the lives that will be lost and the suffering people will go through.
Not even that.
Agree, not good to be short right now.
Uh oh, FYI better close those short positions. Something is coming. Just sayin. We gave entered the perfect scenario for longs.
No it’s NP’s turn to talk about his mother li law.
Thanks for sharing, the news outlet did a great job explaining the process.
Ba ha ha, that’s not happening. Never gone see that price again.
What’s that represent ?
Agreed
You will have more exposure to longs and institutional money. It will be harder for shorts to manipulate the price. You will have margin borrowing, self directed 401k’s, option trading. The risk will always be there but may be mitigated.
Yeah, that’s not going to work. On both accounts.
Nice post, so what are the time frames?
Up list announcement next week
Interim cd12 results approx 2 weeks
Submit HIV BLA Within 30 Days
Do tell?
True statement
The Nasdaq is using the postal service. Thanks a lot DeJoy.
I disagree, the call was good. We keep moving forward and not in reverse. The share price is irrelevant in an OTC stock with no revenue. I have been with this ship when there were just warrants so the price is whatever as long as the process and science are being managed effectively. Would you rather be sitting in this stock right now or not? is what I ask myself regularly.
He only had a few “likes” and it was a pathetic response anyway. He knows he lost. What a coward.
Ha, he just makes that shit up as he goes.
It’s the Jets and CYDY’s year!
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Been using Twitter with #leronlimab and #cydy. Lots of activity happening.
No hate here, just want a fair shake and I am not even a middle child. I appreciate your insight btw.