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CYDY cures cancer, is still broke
Indeed. 'Net Current Asset Value' is the big question right here,
as CYDY's value stock could swing into a massive growth stock
with the stroke of a pen.
The definition of (small cap) developing biotech,
where none of their cash really matters - b/c they will use all of it.
I wonder who the intended audience is for this PR (o8>
A17 good summary, CYDY should have put this list as a subtitle (as they often do).
Yes, the selling partner might be awaited by a quite horizontal market demand giving all the INDs trickling in..
Open PRs:
- 700mg Safety Data BLA
- 700mg Stability Data BLA
- NASH animal model results
- Royalty Deal
- BLA funding completion and filing completion
- More mTNBC data ..
- GvHD Data
- Licensing Deal
- Cancer Basket IND
What a list ..
The bold entries shall act as the financial relieve,
allowing all indications to be realized.
Mostly the royalty deal of course.
Awaiting negative posts in .. 1 .. 2 .. 3 .. Kidding (o8>
LifeSci Partners (Parent) http://www.lifescipartners.com/
LifeSci Advisors (Sister) https://www.lifesciadvisors.com/
https://www.lifesciadvisors.com/our-services/
- Investment advise
- Relationships (!)
- Non-Deal Roadshows
LifSci PR https://lifescipublicrelations.com/about-us/
https://lifescipublicrelations.com/team/
...
Looks quite thorough indeed and well educated and staffed.
Not your windy pump PR company for sure (o8>
CYDY might could use the 'LifeSci Advisors' as well.
I already did in post 49262
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152343852
EMA Support for early access
https://www.ema.europa.eu/en/human-regulatory/overview/support-early-access
also includes: accelerated assessment and conditional marketing authorisation - besides the known compassionate use.
Usual process
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation
https://www.ema.europa.eu/en/medicines/medicines-under-evaluation
So it is quite possible.
In Europe, depending on country, you can use any medicine usually - but you have to haggle with the insurance. So if having said good science and trial support, there should be less issues.
Unlike the FDA, EMA doesn't really forbid you to use a medicine.
(all to my knowledge)
+++
and from my memories, DD'ed the drug application process in Europe 1-2 years ago - you might not even need anything with the proper paperwork.
Keyword: Life saving drug w/o alternatives.
Hmm, hopefully the upcoming royalty partner or related licensee can do that.
Will brush up my DD in this regard later.
Misui, the more I think about this angle ..
I thought more about the fact that these pts only got Leron. as a working treatment, so another confirmation of monotherapy ..
But as you hinted, these ones were sick indeed (AIDS) and no other drug class worked.
Now let us sit back and realize the study was in Europe!
.. and that it demonstrated to be a life saver for these pts
in an independent European study.
NP should send his data available and get an exception or 'CE mark' right away - as it is much easier to get new drugs accepted in Europe.
Especially under these circumstances.
I hope he is aware of that.
Soooo - Impact IMHO: HTE MDR4 pts treated w/ L. -> Monotherapy working!
Hence impact of this study is quite big IMHO,
i.e. no other drug works for these HTE pts but L.
Good morning
A17, IMHO the window of opportunity to buy below 40, 50, .. cents will close quickly.
So just in case you sold some or all and fell betrayed by the suddenly strengthening SP based on the development, it is your choice to watch the train leaving or hopping on.
that is correct, NP said they where all OK pushing out receiving their compensation for the cause in NP's last interview (superstock).
So options in lieu of cash is a like buying stock.
BTS and Ohm20, to my very knowledge about NASH (not much), it is mostly an inherited genetic disease which leads the patients to their fate.
(Removed wrongly assumed Ashkenazi population to be affected here)
Point is that this genetic defect AFAIK (which is not much) leads to the lack of fat processing of the liver and then they get the inflammation.
https://rarediseases.info.nih.gov/diseases/6430/nonalcoholic-steatohepatitis
https://www.middleeastmedicalportal.com/non-alcoholic-fatty-liver-disease-does-genetics-have-a-role/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4945502/
Hence IMHO, one likes to tackle the disease either by the two symptoms (fat and inflammation) or you create a genetic recoding drug to solve the defect.
Now .. AFAIK, the most severe patients having inflammations bound to a critical stage would really love to have an efficient anti-inflammation drug. Here it is very important that the same is non toxic, as the liver is already 'on vacation' so to speak.
Therefor: Leronlimab could be a very important treatment for (severe) NASH cases IMHO. But also gives long term benefits.
IMHO and AFAIK, dropped here for a fruitful debate.
(Don't know what is so funny about this fact).
Thank you Ohm20 and BuyToSell (maybe drop your funny 'Wow' next time).
Sammie, JMartin are you trying to implement something here?
There is indeed a well known list of genetic disorders in certain
populations - science is tackling that. What is you problem?
But it is not NASH but Cystic Fibrosis and others, I mixed 'em up.
Surely there was nothing wrong with my post.
https://www.jewishgeneticdiseases.org/jewish-genetic-diseases/
https://www.gaucherdisease.org/blog/5-common-ashkenazi-genetic-diseases/
https://en.wikipedia.org/wiki/Medical_genetics_of_Jews#Ashkenazi_diseases
same impression. Even though the show started late and he had to get into 'the zone' in the beginning - NP went from yelling at SH to be very sovereign and confident. Good job.
So knowing NP's emotional reflection (not a great actor),
the last two presentations (PI + yesterday) were a turning point probably.
Soon we will know.
I still consider mTNBC much more important and we know our results are awesome - sure, NASH is also very great it seems.
Didn't realize that w/ the partner though .. but I am sure the cancer world just got a BIG HEADS UP a few days ago when they threw in the well considered adjective: SIGNIFICANT.
But let's not argue about which of our great indications will rock the boat higher and earlier - but its a great problem to have (o8>
plavac, don't say it this way.
NP also stressed mTNBC enrollment is his highest priority, which keeps him awake at night.
But yes, NASH is also the 2nd next highest priority milestone.
All this while HIV-1 Combo shall now support the whole venture of course, so that deal we are waiting for to be signed is the deal.
IMHO
CYDY will have plenty of resources (read cash) after closing the revenue deal for Combo HIV-1.
Sorry - didn't know your average is that high.
But yes, I am sure we get above $2 rather quickly on the deal and overall progress, having the worst behind us.
Combo enrollment was tricky - mono should be easy now knowing that all participants will also have their Vitamin L against potential cancer and NASH. No kidding, popularity of Leronlimab should increase dramatically going forward - they will know what we know soon.
Good luck A17
Uptrend on 20dma 31c and 8dema 32c, upper BB half.
BB also opened up, so we might not be surprised of a bit appreciation.
If NP can adjust the next little offering ($5-$7M until EOY) like 40c - 50c as stock walks back up, that would be just great.
Next news in days coming in according to NP: NASH, GvHD (right?) and the deal.
z_smith + saltz, yes it is actually nothing - the $7M or so up until end of January for BLA completion. Then the deal's milestones shall kick in and we should be in heaven as approval will be an extreme high certainty thanks to FDA's micromanaging of the given rolling BLA documents filed.
Phew what a long sentence (o:>
For me & friends personally: When the deal goes through as planned and in progress (so NP) - we can all just focus on the science.
A17 I am a bit tired of splitting hairs of fine semantics, but so be it.
First of all, CYDY needs the FDA blessing to be even capable to start the trial - we are waiting for that. Not in the sole hands of NP.
Second, yes they should start ASAP, but ASAP now is IMHO after the deal closing and FDA IND approval. We talk about just a few weeks now (o8>
Third I would not speculate on the pivotal monotrial protocol at this point in time. IMHO it will be shortened a lot, as safety has been done. But you also confirmed 6-12 month is possible. That's good. Approval thereafter will be fast.
mTNBC enrollment pace can be quite fast by now as CYDY obviously has been getting a lot of attention in the space.
10 email requests in one day .. you may remember.
In this sense, I don't know why you are putting out such a forward looking statement of yours here (o8>
IMHO if we get the 3+ patients injected within January 2020 (NP hopes for Dec 2019), we would be in an excellent schedule.
mTNBC approval could occur EOY 2020 or 1Q21 if further results match the 1st patient, I believe you are aware of that.
FINALLY .. all of the above is good and fine and will elevate stock price much further on progress, NP 'only' needs to close this commercialization deal. Then nobody will be able to talk down the much higher valuation.
If my final note will be matched, we should be a very happy family here putting financial worries to rest and having a very strong pipeline and one commercial indication. But (and this is my only 'but') .. that deal must be done.
Good luck.
HIV Mono IND awaits FDA approval or let's say final negotiation of the protocol. IMHO whether they like to count CCR5 or not etc etc.
Even if they receive that IND right now, IMHO we have to get to our BLA completion and the revenue deal of course - but push mTNBC forward ASAP.
mTNBC will be a much faster trial than HIV-1 monotherapy, the latter could take 6 month to one year. mTNBC on the other hand will lead to very fast results, as we just have seen.
Bottom line: Nothing has been pushed away.
BTW .. have you heard that NP mentioned GvHD in days now?
Good morning.
Good Morning Saltz and all,
well put Saltz, but IMHO the revenue deal must not need to pay upfront cash at all for us to strive hard.
The disclosed terms are already extremely (and I mean really extremely)
excellent and puts a lot of burden on the partner, so he must be good!
The partner is willing to pay for the whole commercialization
on the given milestones (BLA, ..) and then even some extra which easily covers for the milestones CYDY needs to pay.
But the biggest part is the 50% royalty on net sales (WAC price),
extremely good.
Any penny you like to have upfront otherwise would reduce that 12 year royalty, so know what you wish for (I don't want more).
NP's real long lasting mistake was the toxic convertible loan.
The micro financing as we experience these days have no lasting impact,
even the Warrants attached will be exercised and sold for profit and also benefit company with cash.
Heck, even the convertibles at discount will go away and may
they also just be happy with a rising stable price
as their convertible amount is limited and should be absorbed
in a healthy trade.
All we need is the love, dump-ta-dump-ta-dump (commercialization deal).
Oh - the big upfront would simply come from the licensing deal
for other territories, NP agreed upon this one.
(o8>
PS: Freedom of speech rules.
We have great volume already.
The conference starts at 1:10pm ET https://register.gotowebinar.com/register/6216172952753492747
The more volume the more perceived overhead gets removed and hopefully cash to the company raised as well (the new Warrants).
Good.
Dipping below 50dma again, but that's OK IMHO.
43c 200dma for reasonable new support and partial recovery.
mTNBA + deal delayed response
well put, well put.
$4.25 or so is the worst case with huge discounts on all ex-HIV indications and 1B OS - so there is a lot of room above with Cancer etc (o8>
Spreadsheet is well posted, read it.
Uplisting will just happen 2020/21 when CYDY started commercializing 2020.
With the deal and no financing pressure and mTNBC + NASH progress,
there should be no reason why not.
Even if they are a bit impatient and will make a RS for the cause, it should be OK as it would not be an RS to keep the lights on - but to uplist while being successful.
Now I have to step back a little, feels like I am covering CYDY non-stop (o8>
bcgk, I wrote that I have increased my initial pre-event position - which I of course had and have.
I just updated our CYDY update blog https://finesand.wordpress.com/2019/11/14/cytodyn-cydy-company-update-log/
and it gets longer and longer realizing the progress made.
It is not easy to wait before buying much more, that is true.
But seemingly you haven't properly understood my strategy:
(1) I buy pre-event low with a higher risk, but very cheap as of now
(2) I will average up post-event .. that is most easy.
A glass of Campaign to the mTNBC MOA proof is well earned IMHO.
Yes, I am personally convinced a deal should go through by now.
Who knows .. combined with the OFF-LABEL utilization the partner
might be very interested right now.
IMHO my posts & strategy are quite consistent, even though I often get upset about some seemingly non-sense details like 1-2 days ago. But when resolved, also thanks to constructive help here, the conclusion is to be very hopeful.
But I very often smile reading your posts, which are not strange to me at all (o8>
OK, order IMHO: Deal, Nash data, BLA completion and in-between spicing with mTNBC updates. At least all of that is on the plate until EOY.
Ludwig showed me the book balancing right now.
Canaccord was playing the 30c bid - ~31.5c ask range earlier
and now they are on 37c ask (since yesterday afternoon)
w/o a need to push with the 30c bid to sell slightly above.
Even $1 comes in short order already on the ask.
Soon.
you made my day ohm20 (o8>
I appreciate your humor lately, bravo.
Potential partner guessing game...
Months ago I added Roche to my list, as they know the mAB valuation and potential, even though they failed and dropped their own HIV mAB.
This from my memories.
Days ago I thought Syneos might be on the list, as they were quoted in the latest SH presentation. But then others here said they are maybe only a fallback commercialization partner.
Yesterday I got a heads up to put Daiichi Sankyo on that list
as they also know the mAB valuation, selling globally and having an active R&D oncology department also using mAB.
Why a bigger partner? To realize the outstanding gross margin, allowing for disclosed deal terms. Not that is matters, soon we will see.
Just a guessing game.
+++
Daiichi Sankyo, a Global Pharmacy with a strong novel Oncology R&D.
https://www.daiichisankyo.com/about_us/who_we_are/strategy/index.html
When NP closes the deal, you will bow down and kiss his feet.
I am sure of that, as I am very sure that you are well invested here (o8>
Bravissimo: CytoDyn Appoints New Chief Financial Officer
https://www.cytodyn.com/investors/news-events/press-releases/detail/362/cytodyn-appoints-new-chief-financial-officer
Mr Eastwood takes over the CFO helm, being the previous controller and vice president.
May he be more engaged and creative regarding financials,
Mr Mulholland gets the Peter principle honor treatment (o8>
Very good!
plavac you are very correct here
Days ago on 10/23 I DD'ed this claim of yours
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151859699
Also, the initial Combo HIV-1 BLA covers all subsequent sBLA indications,
the latter sBLA for mTNBC, Mono HIV-1 etc will be processed is a much shorten period.
Repost:
On Friday, 06/07/19 04:58:50 AM plavac wrote:
and another funny one ohm20 (o8>
Even at those days I only mentioned it b/c there is always
a varying risk of said capitulation.
At the given time, there was a perception of no progress and no deal.
A standstill sort of.
These days are surely over as we get safety data this month and stability data next month for HIV-1 BLA completion until EOY the latest.
Then we get NASH and we already have an excellent mTNBC MOA confirmation, better than we all expected.
Some cash needs to be raised still, but it is nothing compared to the economics of HIV-1 and mTNBC here. NASH is a bonus.
If NP closes this revenue deal now any day, I am sure we would all hug him and congratulate (o8>
Also, even if the deal 'only' has milestones for after BLA completion or approval (for me that's the same thing as explained), raising the remaining petty cash should be very easily - even at much higher prices.
We will see soon.
A17, I know that you can read and do some financials.
I also know that you often dampen enthusiasm right before appreciation.
No, I even said north of $5,000M (Five Billion USD), so more than this
having one billion OS.
You also understand the logic, as even this number gives a huge discount to mTNBC or HIV-mono, depending what will be valued in first.
I intentionally left our NASH here: A bonus.
The journey should have already started, but it will move dramatically when NP signs the revenue deal. BLA approval is a 99%+ certainty when BLA is completed, thanks to FDA micromanagement of the submission (see safety and stability data). Simple as that.
A17, you are better than mentioning the employee count of CYDY, please (o8>
CYDY just put its toes into the $13B+ Breast Cancer market having proven its MOA by 1 patients and two significant data read-outs.
Yes, some investors will average up as they go and some will increase their position on good results of course. For example, yesterday I broke out of my pledge a little, also added on the results and removal of confusion.
+++
But here again the worst case spreadsheet giving mTNBC a 90% discount, which should be reduced dramatically going forward knowing that early stage discount is only 70%, mid-stage 40% (we are here) etc.
PDF: https://finesand.files.wordpress.com/2019/10/cydy-03h-1.pdf
https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/
Overall economics:
Partnership numbers, use the 2nd block for currently negotiated deal:
Saltz I agree, NP restated the revenue deal on 11/13 any day now in public for all to see and hear. So everybody shall make their own conclusion on that.
No more 'secret email' blurr.
IMHO he will close the deal, yes. (added for clarification)
Usually a CEO would NOT restate a failed deal/negotiation, never ever.
We have all videos copied here and I am sure many do the same.
Still an expectation, but it could be easily proven whether negotiations are still ongoing or not. He is not that stupid on the contrary.
And then we have the outrageously good results from two data points of one mTNBC patient with the added bonus of (solid) tumor shrinkage, which extremely well supports the MOA of Leronlimab.
Personally it is time for me to have a glass of champagne on this after having resolved the confusion yesterday - and I rarely drink.
While the micro raises look a little bit funny, they don't make any difference to our ROI at all. We documented this very well in our spreadsheet for the 1B OS case on revenue partnership.
https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/
As crazy as it sounds and trades, we currently have a stock probably worth north of $5/sh available under 40c.
Good Morning!
PS: Peers hinted to me that one potential excellent match for global partnership including the US would be $DSNKY
IF NP would lie about the data and results released, HIV-1 or mTNBC or whatever - he, CYDY and everybody involved would be destroyed by the FDA, the science community and las but not least by the market.
The FDA usually watches all companies going through any serious BLA or NDA process. It happened not only once where companies were rejected from the ongoing process or even after approval slapped post marketing for violations. When you p1ss off the FDA while being in the BLA process, you better book a trip to Mars, b/c your career would be over.
KobeF, giving this 'debate' the benefit of the doubt (but I doubt),
you should be aware that the FDA even considers the sample size 3 very very significant to issue BTD.
IRB is very happy with expanded access and the FDA issued the IND
and is also quite happy with all results ranging from HIV-1 to mTNBC so far.
Do you even know what would happen if the FDA was not OK with mTNBC?
They would end the trial, b/c life is at risk.
Current mTNBC known data sample size of 1 was VERY difficult for CYDY,
as we could have had one outlier - no good results.
People could even have said that that its not working at all.
Gladly the results of two CTC measurements plus tumor size measurements were not just good, but SIGNIFICANT (to baseline) - if you know what that means.
Stock didn't run up yet, but it could run up just on this result any day now, as the revenue deal closing has been also restated to be any day now.
Good morning!