Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I agree.
Which is why the failure to get it right in April/May, after a year+ of having "rolling submission" from FDA, was and is so incredibly crippling.
Get it right, PDUFA date could have been Christmas 2020.
As is, BLA has not been submitted. Then 60 more days to review by FDA.
Then (hopefully) acceptance with a PDUFA date 6-10 months out.
Remember - this is the same NP that once stated that they would do an interim analysis on the FIRST 50 PATIENTS in S/C. I have been a seller over the last two months also. First time in 3 years.
And that is also where the RTF letter BLA snafu is absolutely crippling to CYDY right now. If BLA had been submitted AND accepted based off of the April filing, we would have a PDUFA date and be looking at approval in the near-term, and the COVID S/C trial interim results would be less of a "make or break" moment.
Two very realistic posts. I agree completely with both.
Congratulations long time longs. Happy to be along for the ride in a very small way. Looking forward to seeing what an uplist does for HGEN.
z smith ... assuming this is what actually happened with 350 mg ... wow.
Just wow.
Thanks for following up. I was tied up yesterday and could not follow.
Appreciate it!
Do you have any sense of timing on the pricing/closing of offering? Thanks.
Tulips, can you please point me in the direction of confirmation that the offering prices today and uplist is Friday? I must have missed that.
Thanks in advance.
Echo this Midnight Rider (and Grip). Been here 3.5 years (God bless you for 7). These are my feelings exactly.
Rockleo ... SH expectations were not unfounded. They were cultivated by CYDY management. Respect you and your posts always, but strongly disagree with you on that point. GLTU.
Thanks Bio and JLA. If what you said is accurate, bio, and I have no reason to doubt it is, then I retract some of my prior indignation about the call. But the fact that this point was not clarified on the call still falls at the feet of management. Good luck to you both
I already indicated I would not be selling tomorrow in an earlier post.
I am also aware I will not get a change in management here. My point is that is a shame, because leronlimab deserves better.
Management actions over the summer have changed my attitude towards this investment, and I have reduced my position accordingly and will continue to do so as I feel appropriate.
I have been in since March 2017 and have an average under $0.50, so it is a very happy situation for me regardless.
GLTU.
And how far out is a BBB indication? 4 years? More? Without capital, good luck moving the trials forward. Without experts, good luck preparing a good protocol (where has THAT issue come up before ...)
My expectations are reasonable - look at my track record of posts if you've been around that long. And no issue with comfort level.
My expectations are competent management, or the BOD finds another management team that is competent. BOD is failing CYDY. Leronlimab deserves better.
Can anyone else confirm what IndexGuy thinks was said by NP?
I agree with your first point 100%. Respectfully I disagree with your second point. It is not the responsibility of you me, or any other investor to maintain the SP.
It is up to management to inspire enough confidence in investors that investors do not want to sell. On behalf of myself and many other long-time longs, management is failing badly in that regard - look no further than your first point.
It IS better to have no call if you have nothing to share. And yet, for 3+ years (at least), that lesson has gone unlearned. It's extraordinarily disappointing to me, and should be to all investors, because leronlimab deserves better. Too many patients, in too many indications, potentially could benefit.
Management impacts investor confidence. Investor confidence impacts SP. SP impacts ability to raise capital from reputable institutions on good terms and ability to uplist to NASDAQ (which should have happened years ago). Capital impacts ability to hire experts, open trial sites, enroll patients, and MOVE THE SCIENCE FORWARD TO APPROVAL.
I won't be selling tomorrow, because the SP will surely overreact, but management is losing the confidence of MANY long-time investors who own significant shares.
BLA update? Can't listen.
"burned too many times" ... the sentiment is mutual. I prefer to think of it, in my case, like I was Charlie Brown and CYDY was Lucy with the football.
A while back, I decided never again. I am still very long CYDY and a believer in leronlimab, but I've checked out a bit from the day-to-day.
I don't even bother to listen to the calls anymore. Anything actually material will either be PR'd or 8K'd. I've already heard enough speeches from CYDY management to last a lifetime!
Good luck to us all today.
Good point re: PIPE offering. I certainly am not hoping for a discount!
Not as long as some here, I am sure, but I own enough to care.
The GILD connection is part of what drew me here in the first place.
It's important to be a part of the big club, and it's a problem if you ain't in it (apologies to Carlin for the paraphrasing - RIP).
I read it to mean that NASDAQ uplisting is contingent on completion of the offering. Pricing of the offering (at least in an IPO context) typically occurs the day before the offering closes.
So pricing of the offering, closing of the offering, and NASDAQ uplist will be a bang-bang-bang sequence of events.
HGEN just has to include the "it might not happen" language as CYA.
Well, I guess that answers my earlier question of who makes it to NASDAQ first (HGEN or "other stock"). Congrats, long-time HGEN longs.
Depending on the pricing of the offering (which will be almost surely at discount to market), it may sting a bit in the short term. If so, I might add more ...
NASDAQ listing will be huge in the medium to long term. Happy to be a shareholder here also and am staying tuned ...
(not just directed at you, Grip. Always enjoy your perspective)
We need to remember it's not an either/or proposition.
The fact that there likely are forces arrayed against the success of CYDY and other small biotech and the fact that CYDY management likely has made some mistakes and sub-optimal decisions at times over the last few years (e.g., Pestell) aren't mutually exclusive.
Can great science trump bad finances and inexperienced management?
The question we are all betting on ....
Good point (first one), and I agree. It was comforting to see HGEN back off of the A/S increase request. I like the capital structure here.
As for the goings-on behind the scenes ... nothing would shock me! GLTU.
RE: the R/S. I am all for it if NASDAQ uplist occurs. Quick research on Friday was that most companies I found that announced R/S for purposes of NASDAQ uplist did achieve uplist. Timing varied from 2 weeks to 12 months.
It will be interesting to see whether HGEN or the other stock (which I own) achieves uplist first. The other stock has not pursued R/S (though discussed it several years back) - instead attempting "organic" uplist.
I've been on the fence, as I believe getting to NASDAQ ASAP is in a company's best interests.
I'm certainly rooting for both! NASDAQ uplist would be huge here. Considering adding to my position here but waiting to see how market fully reacts to R/S.
GLTA.
Press releases from June 2nd forward paint a pretty good picture of where things might be headed. GLTU
https://nwbio.com/press-releases/
Thanks for your thoughts and GLTU as always
He's referring to HGEN, following off of Scooter's conversation:
https://www.humanigen.com/press/Humanigen-Announces-One-for-Five-Reverse-Stock-Split?utm_campaign=5f235f90-bcce-49c6-91dc-2f4bce958c99&utm_source=so&utm_medium=mail&cid=f4f0d283-6d0d-4274-bbb7-f8c35c6dfd07
It will be interesting to see who makes it to NASDAQ first!
I've been away for a while. Getting back up to speed.
Given that LL and MB aren't scheduled to present until 11/20, is the expectation still that TLD will be revealed prior to then, with a full elaboration of the results on 11/20, or is the expectation that we are waiting until 11/20?
My expectation is the former. But it's always best to consult others.
Thanks.
Thanks cowtown jay. Getting up to speed. This helps.
Following along from home ...
It seems some believe the recent downtrend is the result of formerly unregistered shares from the June 2020 offering becoming registered recently.
Any other longs have insight into the recent downtrend?
Appears next catalyst might not be until PIII data late fall.
Am I missing anything?
Thanks,
BL
Wow, nice article. I am on my phone, but someone on the board please archive this before it gets taken down
Makes 2 of us. You're welcome, board, if it goes to the moon after the call today (a la Vyera). And to be clear, I still own plenty of shares ... just taking some long-overdue profits.
Thank you. Is that the trial where PE changed from 28-day mortality to a shorter target?
Any estimate from HGEN on full enrollment, top line data, etc.?
Relevant to CYDY if HGEN has results before 195 interim S/C.
Thanks.
I agree with your post 100%. I am a hard NO on this item unless something changes majorly between now and the vote.
To be clear for the board's purposes, however, the current incentive pool is 25M. They've issued all but 800,000 of that pool, and the remaining 800K is not sufficient to cover promises already made (i.e., incentives already granted). The ask is to double the size of the current pool, from 25M to 50M (so an additional 25M of authorized incentive shares).
Given that they just authorized another 100M shares, it's somewhat galling to now ask to use 1/4 of those shares for an equity pool.
Dropped in today to check on this board. Long time posters may remember I lurked here a few years ago. Had a position, sold it, moved on. Still followed. Got back in recently after the PR indicating TLD after Labor Day. Look forward to the next few months. Lost a family member to glio many years ago and have always had a personal interest in NWBO's science.
Congrats to all those who managed to hang in there over the years (see many familiar names here still). Hoping the future is brighter here than the past 5 years ...
I'm on record multiple times regarding my lack of total confidence in NP and frustration regarding historical overpromise/underdeliver.
To be fair to the man, however, he hasn't once promised uplisting in August.
I agree with everything you state below. Taking those obstacles as a given for the sake of discussion, how are they (or will they) affect your investment strategy here? I am considering the same points currently but have not fully developed my strategy, but I will admit it will potentially lead me to sell a portion of my position before I otherwise would have.
Seems to me the answer to the question should turn, at least in part, on whether you believe CYDY management has the self-awareness and savvy to realize what it is up against and "play ball". Again, I am not sure how I feel about the likelihood of that happening ...
I didn't see lenzilumab (HGEN) or RLF-100 (RLFTF) listed either.
Since the former is partnered with Kite (i.e., Gilead) in CAR-T and is doing a combo study with remdesivir (i.e., Gilead) at NIH, I think, in this case at least, it is more of an issue that the ASPH list is incomplete with respect to mAbs rather than leronlimab being excluded intentionally.