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I see it as very disappointing. Rolling BLA is out, and BLA won’t start for AT LEAST 6 months.
Ok, 235 was close to what I was conservatively / pessimistically guessing. Ok, so we could have that necessary 300 for safety. Relax
Why did they recently open more centers ? They still aren’t that close to 300. Last we heard was 150.
They flatly refuse to give ANY sort of clue as to patient #s , which might conceal a lack of progress.
Really ? Run put of funds ? They’ve shown efficacy in a phase 3 trial for a multi-billion dollar market. Funds will be there.
BP will have to pay a higher price; presuming the data is still very good.
The more time goes by, the more the trial data conclusively proves just how kick-a$$ Pro-140 is !!
Hence the trip to Philly Securities Assoc recently.
4-Traders article
https://www.google.com/amp/www.4-traders.com/amp/CYTODYN-INC-163210/news/CytoDyn-Provides-Update-on-Phase-2-Clinical-Trial-with-PRO-140-in-GvHD-26802701/
They also have an ASM article
That was a tall order. The patients that were required had to be in bad enough shape to have 3 classes of resistance yet stable enough to be part of the trial. Almost a contradictory definition; fortunately not.
No announcement today for HIV combo ? Wasn’t Monday a material event ?
An emoji that got lost in translation which meant I agree
Good grief ! Would you say that The PR’s might as well say, “Mwaa mwuh waaaah wah whuh WAAAAH !”
I imagine this getting a good deal more bizarre before fair value is moved toward.
How do you forecast a change in market size with an improvement in the standard of care ? (Presuming Pro140 is such)
Whatever it is, Pro140 will cause the market to grow substantially.
I wonder, did fda wait to give CYDY this GvHD news until during the Combo HIV meeting ?
If it’s the former, then the company was hoping to take advantage of a jump in s.p. after the meeting.... which they no longer expect to happen. If the latter, then they no longer need the capital raise as in a partnership or grant.
Was the raise already timed to be right after the FDA meeting, or was it scheduled before the FDA meeting was known ?
Jody Cain said the company will hold investor calls (plural) going forward, but the date for the next call has not yet been announced.
Are we back down to the trendline from last July to this January ? Dang !
Sorry, I am prejudicing the FDA on the basis of the federal agency that I deal with at work. They often exceed my wildest expectations.
What is the weirdest €&%* that you could imagine the FDA pulling on Pro140 ? I suppose that depends on the data. Denying BTD, requiring a phase 4 ... I pretty much expect that. Trying to keep expectations SO LOW that I won’t be disappointed.
Aren’t the terms WORSE than they used to be ? Now the company coughs up 2 warrants for every 2 shares purchased. They used to only give up 1 warrant for every 2 shares purchased.
Jody was out of the office yesterday.
That was me. That is mostly angst from that nobody seems to be paying attention.
I don’t think we’ll hear anything today. Long meeting yesterday, fly back to Wash state, rest at home, prepare for PR / conf call, plus normal business, then arrange call. Another busy day today. I just think it will be set for tomorrow.
Holy Reformulated gasoline, Batman !
My thoroughly jaded opinion is that only a partnership or FDA approval will get us over $1. Or uplisting. Fortunately, I am the outlier here.
I believe the answers are : No, of course not yet, no and no.
So apparently there will need to be another raise soon. Sigh.
I would echo those same concerns, but I would call them an expectation instead.
Breast and prostate cancer
Thanks Misiu! I saw one in March 29, of this year that mentioned they thought those areas were worth perusing. I never heard that those were finished.
Wiki said breast and cancer. Very good !
What type of cancer (s) is he studying ? Leukemia’s or what ?
Where are all of these preclinicals ? I have only heard about GvHD. Or do you only hear about them after they are finished ?
The chart might look that way. But with PE results and the soon to prepare BLA .... nnnnnnnnNO WAY !
Yes thanks, someone else (Tom ?) had brought that up earlier. So good to have more of the timeline in the reported not rumored category.
Article on Medpagetoday. https://www.medpagetoday.com/meetingcoverage/asmmicrobe/73424