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There is only one patent, but prev changed applications. Filing data is of the first application in 2012.
A patent's validity is given by it's many _independent_ claims.
A paper describing CCR5 + Cancer MOA will not just invalidate a patent, but it would need to be carefully drafted yes. But this 2012 patent's application was prior to his paper.
This patent AFAIK uses the detection + treatment as one claim plus breast cancer treatment as another independent claim. This from my memories when I read it months ago. Treatment via a wide range of CCR5 blocker.
HOWEVER, there another patent floating around from Germany AFAIK.
Trding once showed it to me, but it was filed after this one (application date). Sadly I did not copied the reference.
Bottom line, this is IMHO not the issue at all here.
ohm20, that is quite a naive way too look at the patent's claim IMHO.
The patent is not just about the fact that blocking CCR5 might work against cancer metastasis - since that would be quite illegal IMHO,
it needs some sort of an operating functional thing.
(Like you should not be able to patent nature)
So the patent is a combo of detecting and treating CCR5 expressed cancer.
But the biggest point to refute your false claim is
excellent analysis MrGuru, thank you.
So I guess they will stay with us for a while and when we get a positive outcome EOY, the volume should help resolving this liability.
Until then, there is also very little they can do - besides the dips and headwind.
Probably NP's biggest ever mistake to take that shark money.
yes Bobby, I know. This was one of my negative points earlier, i.e. NP could have shown details to the deal for an offering under NDA and lock up. It surely didn't happen .. and so forth.
We will see how this turns out.
RP didn't quit, hence he is suing. He wants the 'for cause' being removed AFAIK. He even allowed him being reinstated.
But well, he is also a professional. So his dispute w/ NP is one thing while he still supports the cause.
I don't and never liked this either. But it should have little to no impact on the current affairs here.
Canaccord is bidding again at 30c, well.
I hope the remaining $8M or so for BLA completion required until EOY gets done ASAP. This b/c it will look not great if stock moves up and NP issues new shares below, we know that (o8>
I would like to see it all at once as soon as possible.
Then it is done and the BLA completion on its merry ways.
bcgk, Grip: If there would be NO progress until 12/31, we also can consider CYDY to be done, completely.
Without completion of the BLA there is very little reason to expect they can raise money in the market.
Also all long term holder will have sold.
I would call this the big downfall case of CYDY.
+++
But then, why should CYDY NOT complete the BLA by EOY19?
That is the question to you.
What do they need to complete it?
- $8M or so raised
- Safety Data
- Stability Data
- CMO blessing/coop
Sure, the commercialization deal is still the biggest question here.
Shaking my head so far, but trying not to think to much about it until..
I know you two are having fun ..
Today's opening looks quite weak. The 70k 30c bid has been revoked it seems? Maybe you get some of your shares.
Paulson still at 20c, phew.
May all of this has no meaning soon.
Less than two month remaining.
read the S-1/A: Quick answer Nope.
They are about to double OS with the new dilution filed and effect'ed soon.
This will allow them to have another RS, so some OS is left (o8>
Relaxed some milestone expectations for now
– NASH Animal Data until 11/31 ??
– Safety Data 52 pts until 11/31 (One step for BLA)
– Remaining $8M offering for BLA completion 12/31.
– Licensing Deal still on with same parameters until 12/31 hopefully
– BLA completion incl. stability data until 12/31
– mTNBC Update 1Q20 (For 3 pts data, FDA embargo)
What would seriously help here is knowing the status of the two mTNBC patients today. Maybe NP likes to give an update in this regard at least - w/o data.
+++
Regarding the NP email, I have received a lot of SH confirmation. Especially from trusted ones. However, we got no confirmation from the company herself.
We would still like to see an official Shareholder Letter instead of a video. You know, something in written, which supports the runway into EOY 2019 for BLA completion.
+++
We are soooo close, humor can't hurt (o8>
Good morning!
well put MrGuru, well put
yes CruJones, that would be a nice resolution.
We don't know for sure what happened and I think RP was not at fault here. Long story - we debated that. However, for our current affairs this is unrelated I think.
So how is it traded now. Do we have 30c support back until further notice?
Support range 27c - 30c since the last attacks 10/18 and 10/28.
10/18 and 10/28 were 6 trading days apart, so is today.
Getting curious about the pattern, I wish NP wouldn't have done the toxic notes. Need to check when they are done.
Let's see how the market treats our hidden gem. May NP remove the hidden attribute some time soon with the deal closing (o8>
Waiting game.
BL - that should follow naturally. If NP can close the deal, there will be no more reason to complain at all.
Still he must also finance the $8M or so for BLA completion in parallel, so let him continue that with the 40c average. Looks like he got the financing pledge from these investors probably.
Maybe it also depends on the deal, i.e. whether he can raise the remaining 'pennies' differently. Will see.
(edited) Abstract 2009: Leronlimab, a humanized monoclonal antibody to CCR5, blocks breast cancer cellular invasion and enhances cell death induced by DNA damaging chemotherapies
Xuanmao Jiao, Min Wang and Richard G. Pestell
DOI: 10.1158/1538-7445.AM2019-2009 Published July 2019
https://cancerres.aacrjournals.org/content/79/13_Supplement/2009.short
Publish in the middle of the fight RP vs NP, starting after 6th May the latest.
+++
Recent Advances Targeting CCR5 for Cancer and Its Role in Immuno-Oncology
Xuanmao Jiao, Omar Nawab, Tejal Patel, Andrew V. Kossenkov, Niels Halama, Dirk Jaeger and Richard G. Pestell
DOI: 10.1158/0008-5472.CAN-19-1167 Published October 2019
https://cancerres.aacrjournals.org/content/79/19/4801.short
indeed sjacobs, well we both can have an objective view.
Hence I will only reflect to my previous negative views.
I buried the RP vs NP dispute, as it has no more big tangible impact at out current state. Sure, it might be much better to have RP on board, especially when it comes to 2020 and going forward Cancer treatment presentations and research. But gladly he is holding his stock and even released on paper supporting Leronlimab after he got fired. So RP is also a professional here.
I just answered trding on a more important issue, re the monotherapy ph2 trial.
The original mono ph2 trial was a failure, as it didn't match the FDA expectations. NP wrote a paper about it and identified CCR5 occupancy.
Due to my limited knowledge regarding the ongoing things, I voted for dropping the ph2 trial ASAP and launch the new trial with the high dosage.
Little did I know, that at that time even the FDA might have seen Combo as critical and wanted better safety data - maybe even efficiency was on the edge. The situation was actually worse than we imagined.
In a creative manner and not that super scientific at first sight,
CYDY has modified the ph2 monotrial by adding 500mg and 700mg dosage
to prove that increased occupancy for certain patients simply resolves
all VL failure issues.
What can we say, 700mg dosage did it for sure as expected. Maybe 500mg as well.
Then we received the FDA feedback, they were pleased with the higher dosage and want it for Combo efficacy as well _without_ a new Combo trial.
That was the big positive FDA ice breaker.
Sure, we got to swallow the bitter pill: New 700mg safety data required, which should be completed by now and added to the BLA these days.
700mg safety data will not only support Combo, but the new mono sBLA (extension) application and cancer and so forth.
NP's letter now picks a little bit about it, i.e. KOLs were not supporting the ph2 monotrial change and continuation - but he got the FDA on his side.
This view is supported by certain publications from KOLs
and of course by the FDA, which is happy with 700mg due to their statements. CYDY released the FDA opinion and requests and they cannot lie about it.
I would say by now - finally, what could a tiny microcap biotech have better than the ultimate support from the FDA?
One supportive example is the failure of CYDY to send in the stability data. FDA corrected this lack of data, CYDY will complete the fix now to complete the BLA in December. Benefits of the rolling BLA while FDA is helping to manage the process.
Usually such thing is breaking the neck of a biotech stock. Here not, already resolved.
This is objectively a big change and it takes a little time to put all the pieces properly together.
Yes, I interpreted quite a few items too negatively.
But in my defense - as you can read above - they were on the very sharp edge between failure and success.
Now CYDY made it - my corrective interpretation.
It is only a logical consequence that potential partners are now pursuing closing a lucrative deal to sell Leronlimab.
Good morning.
tony, good morning.
If you read the financial interpretation, aka spreadsheets, of the deal,
it is everything but a pittance for the HIV franchise.
The deal is actually much better than going all alone,
as that would require CYDY to raise tons of cash to even be capable
to sell a product. Hence the 2B OS worst case for that all alone case.
I am a little bit surprised by your reaction, tbh very much so.
But maybe you like to provoke me to elaborate a little bit more about it?
The HIV franchise deal (Combo + Mono) should get
annually $1500M EBITDA minimum and that is the worst case calculus.
I see nothing wrong with that.
CYDY could actually stop everything else and collect that cash for 11-12 years and disperse it to us. That would be a quite some dividends to pay (o8>
However, CYDY will push all other indications first - before paying dividends.
The BLA completion should be the least of our problems. It is just rolling work and then review completion as well.
Just some $8M still need to be raised - no secret.
Again - this HIV deal we know of is the strategy.
When signed as planned and still under negotiation, we shall be platinum.
(1) https://finesand.wordpress.com/2019/09/12/cytodyn-cydy-50-royalties-on-sales/
(2) https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/
Just woke up. Maybe I do not see your actual point of discussion. Please elaborate, thank you Tony.
would be nice if you could make your spreadsheet available like I have done.
Sharing our thought in detail.
ohm20, that would be sad of course (not really) (o8>
Even when I was bearish due to events, I had to be ready for the big reversal every minute. It surely wasn't easy to be negative knowing
what the underlying value actually is.
Well, it was worth it a little, skipping some 20c downwards, but stressful as a long term bull.
I just hope this is finally over and we all can relax.
BTW - the RP vs NP stuff might be entertaining from here on of some sort,
but it is no more relevant due to the new setup.
RP also holds his shares.
I just would refrain from bashing him...
Oh, and NP email is quite positive IMHO.
We knew the deal is still going, but him admitting his fault
in a humble way is a change of heart and maybe management.
In the end, as the letter said, it doesn't matter whether the deal gets signed in October or December.
Good luck to us.
yes, as I have posted ...
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=152069381
This could be a big issue, especially now knowing that the big owners just invested from 10c or below and did not participate in late raises.
Only the loan from one SH is a positive.
So the setup could be indeed to drain value from public to private,
DRYS comes into mind as one of the worst examples.
Here CEO milked the public company paying for services owned by family.
Still speculation!
However, the amount of these residuals especially in a related within arms reach deal must be disclosed.
(EROS is another bitter taster example, easy short attack surface, especially if showing weakness in biz execution.)
Thank you tonysd57,
Tony: 2 anon + 1 known (you are not in the confirm list as a source ofc)
Lorbas: 2 anon + 1 known
I put you on the 'known list' on Lorbas, as I very well remember that all your heads up from the past were all 100% correct.
We got no confirmation from NP yet sadly, but that's OK.
Content of the email matches what we know, OK as well.
Only the closing .. phew, could have been a bit more sober.
But if sky is the limit and the stock follows,
I am sure we are the last to complain (o8>
I still see a $2/sh 'difficulty' and a $5/sh sky limit as of today (o8>
NP, energize!
Confirmations re NP Emails from other SH so far
Tony: 2 anon + 1 known
Lorbas: 2 anon
Waiting on one official confirmation
and one official SH Letter.
Maybe NP did the type due to the 2nd sentence about
his mother in law being a patient.
In the end, he is a human and also not an English teacher (o8>
Read the letter 3 times and I have to say it was
formulated quite verbose in plain English
and in a very direct language.
I usually like that.
So if that really is from him .. KUDOS to NP.
Now time for other things.
it is not easy with this management, we all know (o8>
And yes, the Pestell affair also brought the BOD into question.
So let's hope they perform 200% now, b/c it is their money and none of them is 20 years old anymore (o8>
Insider Ownership Value (Invested)
Because the insider ownership is still very strong
Ownership @ 221.7M OS fully diluted
- 2018-06-05 CEO Chowdhury 87.54M 39.49%
- 2018-06-05 Timol Bashir 27.08M 12.21%
- 2018-06-05 Ismail Sufyan 22.71M 10.34%
- 2017-12-31 Sze Tang Li 4.69M 2.12%
I needed to check how much they potentially have paid for ..
BigBill1- thank you.
A few papers supporting the MARD and other quality values might be helpful?
Yes, I read the FDA data paper 18/12/2018 https://nemauramedical.com/wp-content/uploads/2018/12/NMRD-Clinical-Presentation-18-Dec-2018.pdf
Yes, the CE approval gives some support. I agree.
Sadly no peer reviewed or independent lab confirmation of the numbers right?
The whole DallasB stuff is quite new to me and yes, disturbing.
Why giving such an 'interesting' party this opportunity for the US sales?
The website and re-branding is a disaster.
I also see that time to market has been broken a few times, I get the frustration.
Also possible QA issues with production .. The Pharma private sub and ofc clarification of costs and source of the insider shares.
Need to dig further ..
Yes yes, first 180 days $1 bid deficiency ends 2020-01-11.
Then they need a plan inclusive SH vote for RS to apply for the 2nd 180 days and so forth.
The private loan from one SH below 10% rate was nice of course, as the $19.39M ATM with MAXIM is still hanging over ones heads.
In this regard, the valuation of insiders shares might be important.
Those 2 email pieces lately .. (Lorbas!)
Both supposed to be from NP.
I do believe the fragment from tonyd, as it just reiterates NP's latest statement from that radio show etc.
yeah well, NP is not the only person in charge. Our wealthy and biggly invested BOD still watching him - and I must assume THEY ARE WATCHING HIM NOW lol (o8>
Grip, that is the only risk I see here, but ..
Meaning a deal will eventually come through anyways.
But of course, we must assume that the deal gets written by lawyers
from both sides. Haggling every line re performance and indemnification.
The usual.
It takes _TIME_.
It more depends on the lawyers consulting NP here and the overall protocol negotiating than NP alone of course.
No layman could handle such a deal on itself.
I was analyzing CLSD's deal, at least what was given to the public.
Knowing their expected performance ($30M per year) I knew that giving
that amount as upfront or milestone was already good.
They get only 10-15% royalties after the initial $30M though,
that's the big discount due to cash needs and poor negotiation.
Still .. they need the money and went for it. SP continued up.
CYDY is another beast with known multiple shots.
The one big HIV partner, if trusted - we are all good.
For contracts I have a very simple thesis. You negotiate hard on eyesight, regardless whether I am the poor servant and then you put it away, hoping to never ever required it to be pulled out and argue with your partner.
This is crucial for a long term fruitful relationship.
Hope here is the same.
Soon we will know.
Platinum ending or mud wrestling (o8>
I am sure tony knows very well we are heading to $150M EBITDA for Combo.
We all should know that with our pipeline this should bring P/E to >= 20, while Mono and Cancer is in pursuit and hot then.
There was also no stock weakness Thur-Fri, even though the self imposed deadline was about to be broken. Especially no Fri sell off, on the contrary.
Yes, our models are very conservative.
Now waiting from another friend's confirmation about certain emails (o8>
tony, the commercialization deal must contain a performance clause of course. Otherwise it would be possible for a BP proxy to enjoy this deal but not selling one dosage and hence stopping the drug. Since such risk is well known in general and CYDY must keep options to move to another partner in such case, I must assume that such clause is written into the deal.
(^^^ re: shelved the commercialization)
So if GILD wants to stop it, they really would need to buy CYDY - all of it.
MOA 'Reverse Ionotophoresis' Proven?
One critical (personal) review paper https://www.nivglucose.com/The%20Pursuit%20of%20Noninvasive%20Glucose%206th%20Edition.pdf
mentions the risk that these devices may read sweat instead of 'bodily fluids' glucose ions, received by the anode.
Do they have anything peer reviewed or an independent lab validation test?
EDITED: You can find some papers on the issue also related to GlucoWatch, but has this concept being proven solid & stable and validated by an independent lab?
I am aware that if this would work with a convenient device (with longer battery power than 12h of course and one replacement battery for loading while wearing) .. it could be the holy grail (o8>
Incorrect? Maybe you learn about the semantics a little bit.
Leibniz and Pythagoras as well and many others might have touched the issue independent from each other or knowingly .. what gives.
For sure Leibniz was (also) right on his findings - and so my statement.
However, in the case of A. Einstein, it is well known that it was not him finding the energy mass equivalence equation first - neither the rel. theory was him first. A weird situation for Einstein.
But heck, he got a refrigerator, photoelectric effect and surely a lot of patent reviews done. (o8>
Sad that he associated himself with the Manhattan Project though, but vanity lead many Germans to participate there sadly.
Common notion of this, it were the mathematicians who nailed down the proper formula in all these cases.
https://en.wikipedia.org/wiki/Olinto_De_Pretto
https://en.wikipedia.org/wiki/Henri_Poincar%C3%A9
https://en.wikipedia.org/wiki/Mileva_Mari%C4%87
Bottom line, it is usually the evolution of theories build and resolved by many.
See Leronlimab, first it wasn't dreamed that monotherapy would be possible - now we await pivotal ph3 kick off and inclusion in the commercialization deal.
This N. Medical <-> N. Pharma relationship is quite fishy,
could allow owners to use N. Pharma to drain 'public' money into their private company?
- NMRD (Nemaura Medical) owns 100% of Region Green Limited
- Region Green Limited owns 100% of Dermal Diagnostic (Holdings) Limited.
- Dermal Diagnostic (Holdings) Limited owns 100% of DDL and 100% of Trial Clinic Limited (TCL)
- Nemaura Pharma (NP) is an affiliated Company not owned by NMRD.
- NMRD and Nemaura Pharma (NP) share same address and officials.
- NMRD outsources jobs to NP (money flow)
- NP also contracted to do the SugarBEAT manufacturing
I also like to learn when and at which share price did the three insider purchase the 87.5M + 27M + 22.7M shares? This number hasn't changed (much) since the initial Form 3.
So I must assume these shares were acquired via an M&A transaction much earlier? This thought regarding CEO & Co valuing their ownership..
.. and I forgot, why did they swap their common shares to preferred shares and back 2017-2018?
Leibniz is correct here, you eventually get there (o8>
https://en.wikipedia.org/wiki/Infinitesimal
BTW, NP's restatement is no news - so he could just restate what he stated the last time anyways. No change. Deals comes through.
I know, this might require one to jump into believe. (Grammar?)
But, so is my stock experience, sometimes you just have to do that.
And I know how hard that is with NP (o8>
However, as the drug is real and proven, it makes no sense that there is no partner.
NP also would not intentionally lie about the NBA.
Hence the most logical & simplest conclusion is: There is a deal.
tonysd57 - Thank you big time!
I now have an external confirmation of a similar statement like you have received from NP.
Of course, same partner for whole HIV makes very much sense.
I do not agree with your negative view on the deal at all.
As you have seen in my calculations
(1) https://finesand.wordpress.com/2019/09/12/cytodyn-cydy-50-royalties-on-sales/
(2) https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/
50% royalty on net-sales (which is simply the WAC price) is tremendous.
It needs a very good company to squeeze out profits for themselves, hence a very experienced company.
As a rule of thumb, 50% Net Profit (EBITDA) equals to roughly 22.50% Net Sales using industry averages, see the page in my spreadsheet with references or https://link.springer.com/article/10.1057%2Fjcb.2009.13
Therefor, this deal brings in all required funding for all other indications, starting with around $150M Combo + $980M Mono.
This deal is not even intended to pay for EOY BLA costs, as NP said on the SHM CC - I understand it as orthogonal.
And royalty on sales always beats upfront money.
One would have a hard time to negotiate (more) upfront cash
w/o giving a bigger discount to royalties.
Expectation hence:
- Complete the remaining $8M BLA funding (or take a small loan)
- Get the great deal 50% on net sales
- Show more data
Financially these events would make it the platinum quarter for us
and the SP will naturally being corrected.
It also would mean that the going alone with partner strategy works out,
which was one of my earlier concerns.
So I am quite pleased!
(I know you also do the financials, hence I have a hard time to grok your none excited view on the deal.)
No, the $10M BLA financing until EOY was orthogonal to the partnership deal as that is suppose to kick in after BLA completion to pay for post approval production ramp up and so forth.
Hence the financing is no big indicator, but I would prefer to see it at once in one filing and not like 6 of them (o8>
The terms are at least OK'sh and a bit above market price around 40c.
I truly would have structured and promoted this last offering very differently: Last raise b4 approval & revenues and so forth. Rights offerings and what not - while showing the NBA under an NDA.
And for the 'no deal yet' bashing, let's enjoy the data catalyst trickling in until EOY: Safety, NASH, TNBC, ..
Eventually the partnership deal shall come through.
At least the NBA must be real, as you could ask for the paperwork in a discovery process.
Sure, as long no such signed deal comes up - NP sucks.
Thereafter, he will be everybody's darling (o8>
Feels like everything possible has been said now already.
Good morning.
It is surely easy to look at the current price and restate that (o8>
Now the hard part is where we try to project the future, where is my time machine?
So we only can use all our experience trying to predict the next events and act accordingly. Experience from CYDY's past and also other companies.
Sometimes they get deals right before approval and SP moves slow at first (CLSD) or even dips a little after approval (FOMX) - all late examples.
Well, both examples have a thing in common, they were quite cheap and one was able to calculate the right value. Now their stock is adjusting.
CYDY seems to be valued at the worst case possible now, 30c is on 2B shares and HIV-1 Combo alone to my latest spreadsheet. Multiples below fair value as of today. https://finesand.wordpress.com/2019/10/20/cytodyn-cydy-worst-case-valuation/
Why is that? I call it the extreme discount based on poor fundraising, past toxic notes, NP past performance .. and whatnot.
Gladly we have multiple ice breakers in front of us, each capable of starting to correct the value. Most notably Partnership deal, BLA completion and TNBC data.
We all can b1tch about the low SP we want. We won't rise it nor lower it by our statements here at all.
But we could try to realistically work together _when_ the fair valuation can be achieved - around $2+ for current affairs worst case and old cheap annual sales price, IMHO.
Yes, we can also debate what the fair value might be - fix the models.
This could be of benefit, as I am convinced that the hardest and most important part in investing into biotech is TIMING.
Today I think it should not hurt to have a few shares CYDY in the account, just in case one of these events just happen. Averaging up is always possible - buying dips might be quite nice - or simply accumulating into EOY.
SONM's FCC Applications https://fccid.io/WYP
(newest one at top)
- 2019-07-31 Sonim XP3 PG2212: WYPPG2212
- 2019-02-02 Sonim XP3 PC2223: WYPPC2223
- 2018-08-16 Kenwood KWSA80K: WYPPG4032
- 2018-07-02 Sonim XP8: WYPPC4000
- 2018-06-26 ACX04G XPand Direct Mode for XP5 + XP8: WYPACX04G
and so on and so forth ...