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Seriously, how hard is it to do ONE THING right?
No PR pre market is disturbing
This “Next week” statement is an opinion or fact?
This info is so nice. Thanks so much
The results can’t come fast enough. Is it realistic to expect results next week?
200 shares traded, jeez
Tony is the best thing that ever happened to CYDY
This is the only potential RS I’ve been in to uplist instead of “keeping listed”.
That’s the one reason I’m staying in.
Are we bottoming here? Can’t be too long before we see results right?
First questions where awesome!!!
Well would be great to receive an answer on:
On HIV
- timeline
- how close we are to 50
- how close we are to 300 at 24w
- when data becomes available
Others
- how far they are with GvHD
- update on other deceases like cologne cancer
Thanks for your reply. The silence was deafening ;)
Is Saltz still with us?
I’m less lucky. Stuck here with 70% loss
Haha of course. You’re the light in my life ;)
Reply
“I don’t want to be the light in your life, just stating “facts/opinions, bla bla”
You still in?
Does anyone expect data tomorrow at the scheduled call?
Well today is another one of those days :)
103k on the ask at .63
Hope all is well. Wondering how you perceived the news.
Great post! Like the way you think.
Also the mono study is open right? So it doesn’t matter indeed.
Does this mean they can unblind the data for the first 40?
Hoping as well that someone is able to find out about that data
Are we rich yet?
CytoDyn Provides Update on PRO 140 Combination Therapy Pivotal Trial in HIV Patients Following Constructive Meeting With FDA
Investors
Interim efficacy analysis of primary endpoint to be conducted in coming weeks
Company to hold investment community conference call on October 19
VANCOUVER, Washington, Oct. 13, 2017 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB:CYDY), a biotechnology company developing new antibody therapies for combating human immunodeficiency virus (HIV) infection, announces that in a meeting held on October 12, 2017, the U.S. Food and Drug Administration (FDA) confirmed the number and type of evaluable patients required for submission of a Biologics License Application (BLA) for PRO 140 as a combination therapy.
The FDA accepted the 40 patients currently enrolled in CytoDyn’s Phase 2b/3 pivotal combination trial as evaluable and further agreed that the trial’s Data Monitoring Committee can conduct an interim efficacy analysis of primary endpoint. The FDA also confirmed that 50 patients will be required for the completion of this trial and agreed to allow more flexibility in the enrollment criteria for the remaining 10 patients. As a result, the Company expects to complete enrollment within the near future. The FDA also confirmed that 300 patients will be required for the safety analysis in a BLA, which can be provided by all of the Company’s HIV trials, providing that those patients have been on a PRO 140 therapy for 24 weeks.
“We are very pleased with the clarity and direction provided by our meeting with the FDA and are now focused on a successful conclusion of our pivotal combination therapy trial in the near future,” said Nader Pourhassan, Ph.D., CytoDyn President and Chief Executive Officer.
CytoDyn’s management will host an investment community conference call on October 19 to discuss the FDA meeting and other business updates. Details of the call will be announced at a later date.
PR is out. Need 10 more patients. Looks like a great summary and moving forward.
Same as your last post 17544
This is a very informative post. Thank you very much.
Can’t get enough of these posts. Thanks so much
BOOOOOOM
Haha roflol
If they open an E*TRADE account (or others) they can immediately start buying.
If they have great news, I can see how this RS could work.
The order is interesting:
1. FDA talk and PR
- bad news, co is done (IMO)
- good news: 3w for data (stock up)
2. RS 15:1 approval in Nov. So this is while they’re processing the data.
3. PR the data (stock shoots up)
4. RS
The order of 3 and 4 are interesting.
If they first RS and then PR the SP would explode. The other way around the shorts will have a good time.
Bad RS (I’ve been in):
- BGMD (went dark)
- GEVO (4 already)
- FH (used to be VRNG)
Good RS (wasn’t in)
- PCLN
Thank you by the way for these questions. Focuses on the real deal
Should be since it’s open.
Thanks for your post. Good to see progress in the rest of the industry.
Technically Cydy has been able to get 30 patients enrolled ;)
Meeting is quite some time after the FDA meeting.
Any expected price movement based on any PR regarding the meeting should be done.
Let’s hope it’s positive. No way to see which way this goes.
I had a chat with Jody. Only asked questions she couldn’t answer ;)
Like, will you be PR’ing more info before the meeting.
She didn’t disclose anything (of course) other than answer my question about “no more money”. She said they always been able to raise money...
Excuse me for my grammar.
Yes. An emotional roller coaster for 22/23 days.