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good one grip. Almost as if NP holds Leronlimab captive, a drugnapper.
So what I read here .. if true, Tony voluntarily left and Pestell, still young, tried to fight it through, but ultimately got fired.
Well, NP gave the suitor, potential partner, a deadline.
Maybe that was also an act of desperation/hubris?
Soon we know.
Nothing new in the article. We discussed it here. Partnership or bust (more extreme dilution).
So I got the reply that the BLA delay forced NP to show off a potential deal?
The BLA delay was well known and hinted earlier, still due this year.
Oct: Safety Data
Nov: Stability Data
But such announcements supports funding, that's for sure.
Next week we know.
More of the same or a big surprise.
Funny price action, better than imagined.
he surely meant 'aggressive' or 'hawkish' licensing partnership announcement. Lost in translation, my dear ESLs (o8>
Sure, NP knows that and it shall not matter at all.
Our official calendar 6 weeks are over.
On the Nader Timezone (lol), 6 weeks ends 10/31 'or so'.
From other's communication with NP, he at least admitted that other deal(s) felt though earlier. This is something he should have told everybody, being humble and transparent.
So next week - Nader Timezone - it is.
Why failing on self made deadlines?
AFAIK this is a deadline he gave to the potential partner to make up their mind.
The preferred C sales was OK, even though the 30c Warrants contained an anti-dilution thingy AFAIK. So we also know that market is not too willing to hand over cash to NP. Needs the deal.
But if the deal doesn't come through, I would think NP totally ruined it.
Why did NP even need to mention the potential deal comes to mind.
????
is it so hard for you to stay on topic?
this BS is scaring people away, as they seemingly only see a bunch of idiots (me included) fighting for nothing.
GN and let's hope NP finally gets it done.
the only thing here are maybe 50% on sales, as that is very very very high.
at least I don't know how that works re profits of the licensee.
Hence I would be happy if its >= 20% already, roughly 50% of profits.
What ware the chances? Market says less than 50/50, otherwise SP would be much higher IMHO.
EDITED: Must not mean a thing of course. 11/1 (o8>
I thought by now you realized that if the market is not appreciating the medicine - or management ruins it, equity will decline for a long time.
This is what we are seeing here for years.
The deal would change all of that.
misiu, the SP fluctuation is coming from the toxic notes not retail.
Who made the toxic notes happen?
At the time they sold them, CYDY was at its darkest moment and funding otherwise has dried out.
CYDY is not in a position to get funding for going alone, at least not today.
What I or our group is doing is simply reflecting the status quo, nothing else - describing the tension. Call it journalism.
But the risk is real of course, so is the potential upside.
However, I hope the deal gets through and all is good.
Nothing is guaranteed, hence the SP.
misiu, the spread _is_ real, it is nothing I create
If there is a deal, god bless NP and we have a big upside - no massive dilution required to commercialize (ask Fortuno).
If there is no deal, I hope 20c will hold.
Simple as that - and yes, sadly a binary moment now.
I presented both cases.
Grip, I am really sorry you didn't buy more at the dip
I explicitly asked you.
But as you know, it doesn't really matter when NP announces partnership.
After the runup the difference 26-32c will not be visible on the charts anymore (o8>
bcgk, no, what is ridiculous is you ignoring the numbers, which I have all laid out.
If market is not considering the success of a partnership deal as of now, so be it.
But with that deal, BLA completed - approval a high probability, it will go to $2+.
Funny those bears w/o any fundamentals.
Try harder.
I have the bull and bear case at hand, all based on fundamentals and the extreme spread exists as for all biotech.
Zuess, so you think he is great talking with his colleagues of other companies? Good.
Only a friend of mine had an email convo back then. Yes, he was nice.
Valuation wise, with the deal, SP should be $2 by now - still having a discount of 30% and low P/E. So that is known.
If the deal gets done, we should see a good correction.
That alone could bring in cash via Warrants.
A vote of confidence by exchanging the Warrants and holding would be helpful.
So .. deal or no deal for up to $191M annual revenues on Combo.
All IMHO.
In comparison, CLSD licensed XIPERA pre-approval for 20% on sales today, i.e. ~2.5% below 50% profits using average margin & costs.
This is considered a great deal actually (o8>
But they got an CRL plus additional data request + FDA meeting (so no clean slate Class-1 review). They aim resubmission complete in 1Q20.
XIPERA and its injector is eye care related only, modest revenue.
OFF-LABEL
On Friday, 06/07/19 04:58:50 AM plavac wrote:
I agree that the Combo dosage boost requirement was questionable by FDA.
It should have been either or .. either allow some sort of mono therapy with high dosabe already or stick to the plan.
We just don't know all details, but it was at least a vote of monotherapy confidence. The double edged sword, yes.
Maybe the FDA should allow at a certain safety stage (no harm) to have patients chose their drug ... but that is another debate.
Little Compilation of DD (Update 2)
EROS presentation q1-fy20
-- http://erosplc.com/wp-content/uploads/2019/10/Q1-FY2020-v2-min.pdf
Since short seller attack and CARE rating drop in June:
- 20-F: Sarbanes oxley (SOX) compliance
- 20-F: Increased institutional holdings
- 1Q20 ER https://www.businesswire.com/news/home/20191008005513/en/
- Already cash flow positive with small profits in last quarter
- Forecasts to become free cash flow positive by year end
- Partnerships with OnePlus TV, WASU Media, Jio
- WASU 2019-08-19
-- https://www.marketwatch.com/press-release/eros-now-announces-china-vod-distribution-deal-with-wasu-media-2019-08-19
-- https://www.crunchbase.com/organization/wasu-media-holding
- Partnership with Microsoft Azure: AI Dubbing + Seamless video platform
- 10/8 1Q20 ER CC
-- https://seekingalpha.com/article/4295602-eros-international-plc-eros-ceo-kishore-lulla-q1-2020-results-earnings-call-transcript?part=single
- 10/17 - 10/18 RIL Earnings 2Q19
-- Showed steady growth ~25% in mobile subs etc, excellent ER
- 'Laal Kaptaan' released 18th October 2019
--
Ohm, delays have occurred due to tight money supply. So Saltz is correct here. Otherwise FDA has not delayed anything IMHO.
I actually like the baby step going forward, i.e. send FDA something and if required, fix it. No real big CRL (o8>
That's why I believe if the BLA is done, it is done.
But the cash was always an issue, no news here.
Well, assuming safety and stability data is coming in now,
remaining cash being provided by willing investors, it's done.
I am willing to give them the benefit of the doubt now,
as next days could be dramatical for company on the upside.
And if NP fails .. well, we are back to 'normal' (o8>
My reasons for either get him replaced or force him to improve:
- Networking, raising money (hopefully a requirement of the past soon)
- He needs to work on his talking style (o8>
I don't know how he gets along with other CEOs, nobody knows.
All I know is he wasn't able to get tutes invested other than the BOD.
History of BOD: He found them, they invested and became part of BOD.
So at least he got that right.
For sure, he must finish HIV-1 Combo (partnership now and approval),
then - if helpful - he may stick with his presidency only?
However, commercialization should be of no more concern with NP,
as we should have a solid licensing partnership.
So that is being dealed with.
From then on, NP's functions should only be:
- Talking face of CYDY (o8>
- Managing other indications with FDA
So after the deal is done, KUDOS to NP then,
his replacement is not really required anymore .. maybe.
And to Nader Pourhassan: If you make that deal happen in the range of 22.6% - 50% net sales (50% - >70% profits), I bow down to this, your achievement.
Because such awesome royalty will finance CYDY's Mono + Cancer with $115M - $191M per anno, likely.
The licensing partnership was always in the cards and will resolve the whole 'going alone' issue, i.e. no need to dilute the hell out of the stock to run marketing on our own (Fortuno's 2B OS).
That's why the partnership deal should correct SP dramatically IMHO,
i.e. quickly a $1 - $2 move.
yes Saltz, but please after HIV-1 Combo approval 1H20.
Mostly viewers of course, threshold of becoming active is high.
But 10 people were sending me questions via PM.
The most readers are re CYDY, only one time SoS posted a very brief bearish warning article about HMNY which were hit astronomically (o8>
Around ~10k unique viewers of CYDY
I may consider the chart to be in uptrend, for adding shares.
I have received quite an overwhelming response of new viewers on my new blog post across the world.
The preferred C are higher than the worst case, avg $0.40 (Warrants + Premium exercise) if company is delivering.
Third day and D candle is already a pregnant mother (not baby, lol).
Similar but much better than 9/23 - 9/25.
T-Line 8dema @ $0.3190 and ask at $0.32, with getting back $0.30 support.
8 trading days left until end of this month (deal anticipation), if I am not mistaken.
May NP deliver.
the fun thing probably is, if NP delivers the licensing deal, SP should walk through the Warrant barriers easy and funding is secured (o8>
Depends on Warrant holder, but the long & wealthy then should just do it, similar to Erik Sprott or John Doerr alike - supporting & pushing.
A few days left (o8>
as I have stated, yes (incl in my summary -> interest)
they always had 10% AFAIK
Most important: Longs are buying it. Simple as that.
Doesn't matter if they print 100M shares until BLA done.
Good, Preferred C again = insiders, BOD probably
C: $1M / 1000 c = $1/c
- initial conversion price of $0.50 per share
- 10% interest
2.5M Warrant Shares @ $0.30/sh = $0.75M
These were regularly bought by BOD and you may want to consider that bullish.
Interesting: This deal is more expensive than the previous TO.
https://www.sec.gov/Archives/edgar/data/1175680/000119312519271269/d820679d8k.htm
I guess the point has been made clear by now!
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=150037756
(o8> Yes, wait and watch.
Hilarious, our dear A17.
Leronlimab PRO 140 HIV-1 Combo Status
======================================
Done
- Efficacy (and FDA likes it even at higher dosage w/o new trial)
- CMO (IMHO also about to be done, stability data done EOY latest)
- Rolling review, FDA check when delivered
and allows correction (hence stability data completion)
TODO
- Safety (coming up soon Nov'19)
- Stability data until EOY '19
- Certain payments (CMO, ..)
- BLA completion paperwork
Lots of the delays occurred due to the open process (rolling review) with FDA, i.e. safety and stability.
This is usually where other stocks dip hard.
(CLSD got their CRL finally, besides stability one addition data request)
If issues can be cured quickly, market may forgive (CLSD, CYDY, ..)
Commercialization Outlook
=========================
Having one licensing partner signed an NBA. Ratification of final contract expected next week until end of month.
This NBA says partner takes costs for commercialization and gives a good chunk of royalties (50% on net sales).
No further financing needed for commercialization.
https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/
+++
Other parties are interested and received access to the data room.
Financing
==========
Independent of licensing partnership, CYDY needs $10M - $15M to complete the BLA until EOY 2019.
Even in the worst case $15M/$0.20 = 75M shares this won't dent the economics, calculated with 1B shares partnership model or 2B shares going alone.
Risks
======
(as I perceive them, none of them is very likely)
- No $15M financing available all of a sudden (after having raised over $200M??)
- FDA doesn't approve - doesn't likes the data (all of a sudden).
- Interested licensing partner runs away (why?)
- ????
Bottom Line
===========
This is a late stage company by now.
All elements of bringing a compound to market has been already addressed.
The only perceived weakness is
- weak balance sheet
- company and drug not well presented in the market yet
- management style, especially NP's way of talking
- poor funding instruments until licensing partnership
- tired investors listening to NP and waiting and waiting and waiting (o8>
Strength
- Strong acting drug w/o serious side effects
- Proven on HIV-1 Combo
- Lately proven w/ 700mg on HIV-1 Mono, but needs refined pivotal trial
- Drug also works in many other indications, including metastatic cancer
Big potential for a suitor.
I touched this idea as well yes, but it is not in the economics spreadsheet they will use for negotiations. Parameters maybe, upfront cash. Sure CYDY is not too strong financially for a tough discussion. But in the end, both want and need to survive to make a profits.
OK, the other thing was for the lawyers. Probability of the existence of the NBA. IMHO NP could not have lied about it. It would have been a severe crime and he repeated the deal multiple times.
So I would stick with your opinion here - deal probably is real.
At this price, it almost doesn't matter how the deal for combo ends up as long it is profitable enough to also finalize mono.
SP has nothing to do when negotiating these partnership deals, as they should be based upon the economics.
Sure, if company is 'cornered a little' financially and wants upfront cash, NP should take 30% of sales and upfront. IMHO much better anyways for Combo.
Later he could do it differently.
Only in a buyout case re Warrants etc SP might play a role.
If we wouldn't know better, one would think a BO is in play lol (o8>
Go NP, go - even Saltz is salty now. If he sells, it would be worse than the note holders.
(Hi Saltz)
Re CEO replacement. After the deal is done, I would also agree on that.
NP might get a BOD only position then.
But now it is showdown, as you say, no?
Would like to have the opinion of LM and BL, i.e. if you could ask for documentation on the NBA just in case.
I doubt he could have lied on that w/o being liable?
Even a fake dreamcatcher salesman would think twice I think.
But still, strongest long support is the BOD.
They didn't run for their money yet but even bought more last months at the TO.
Crazy situation.
GL
bullish side is SP > $1 on a deal, should run to $2 having financing secured.
the plunge here could be anything of course, probably note holder yesterday.
in the past it took 2-3 days to recover, bounce and slide again.
by that time we might have a decision.
scenario set, go (o8>
Worst case on the assumption of a deal and financing:
https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/
There was a factual bull post (other board) listing his late achievements.
Well .. Samsung Biotech has been used and they allow CYDY to pay late.
Then the TNBC first injection (official trial).
And the NASH thingy.
Anything else?
Sure, he failed a lot of timelines as well.
The NP timezone (o8>
So he is not that bad, but surely needs better communication skills.
Maybe a professional writer for written PRs, instead of these videos.
Just an idea.
Yes, but I stated that pre CC b4 Misiu asked the question.
After that conference I was corrected and I also restated that.
You have to admit, NP is a bit clumsy in communicating all of that.
NP (if you are listening): Do it all in proper writing.
It is not too hard (o8>
We are still waiting for that data release and I hope NP does a proper announcement.
You have do admit, NP needs better communication skills.
re safety data, he enrolled more in the now ended mono trial. I figured and was corrected. I am not 100%, but close lol (o8>
As with all biotech .. there is a financial risk, but I also stated that such risk is very low and I don't believe in it.
man up (o8>
balancing on the edge, 31st Oct we know more I guess (o8>
I always made my sentiment clear, not manipulating.
I wish they succeed and we all get a bit more wealthy.
Now on the licensing + financing event risk,
if that is mastered - a clear GO (at a higher SP price).
Buy the risk now for (much) higher returns if you wish.
Known fact: Science and Combo data is great. Safety will be.
It is not that complicated.
Chances of NP fails to get financing equals to the chances of financial distress. Are they high?
(IMHO: They are low, but darn .. suspense is here)
So emotional swings are understandable, yes.
bcgk - just a personal note to your writing style.
It might be more liking that maybe you are being paid for?
Who has such interests? Buyers ATM or the note holder (o8>
Seriously, the lack of quality of such outbursts only
supports the bull case.
Maybe learn from A17 and Suvorov (o8>
EDIT: I dropped myself here from the list to not look too arrogant (o8>
No shorters here I believe.
Just the usual sshow (o8>
A17, Suvorov, et al.: BLA completion now hangs on:
- $10M - $15M financing
- Safety data (these days)
- Stability data (easy now)
So it will be financing deciding whether BLA can be completed this year I guess. Old story.
Now if NP is doing the licensing partnership deal, it should help with financing - still MIA.
End of this month (his deadline) we should be more knowledgeable I guess.
If he shows a licensing contract, financing will come easily.
If he shows financing, even at 20c 75M shares, BLA will be a fact.
Agreed? Would like to have the reply from my dear critical friends as well.
If NP delivers, the SP rise would be quite steep.
Otherwise .. no need to debate (o8>
In this sense, we just need to wait.
sure, possible and sensible as suitor would want to have that as well
when I played with the numbers, 50% on net sales (less rebates),
is A LOT to be honest.
reason why I added the 30% on sales case, knowing that ~22.6% means 50% of profits on average pharma costs/margins.
so as a heads up: If NP gets a deal done for >= 20% on net sales, it is already awesome - just that people understand the numbers.
From this number on, the pharma is willing to earn less than the IP owner CYDY.
How could a pharma offer such a high percentage of the whole cake, i.e. 50% on sales -> 70%+ on profits? It must be a really high margin, low production costs and sort of no advertising required.
IMHO a BP not a small one - at least a very experienced one knowing their numbers pretty well.
Just a little debate on the details ..
EDITED: Or .. they get a bigger cake for another country. Also possible (o8>
that is a possibility with the partnership, when HIV monotherapy gets financed through the HIV combo payments.
Then the combo discount should be zero,
mono discounts should go to 30% late stage
and maybe the cancer discount also lowers a bit.
Then one might assume mono would get real soon w/o funding delays and when that cash trickles in on similar partnership deal .. it goes.
Ice breaker would be this anticipated and promised deal yes.
Hero (deal) or zero (no deal as of now already).
That explains the tension right now.
(o8> <o8)