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Dear TheGame
Captain Crunch posted it best IMO. This is all speculatory as to when this flower will blossom, however, it is not a matter of IF it will bloom just a matter of when it will bloom.
With current work in India on Herpes using a topical cream I would give it at least 2-3 years before we see anything of significance in the US. Overseas will probably be a much different story as other countries in most cases do not have to contend with agencies as scrutinous as the FDA. In India and China things will probably happen much faster. How much faster I can not say.
As summer sets in and the market becomes non-eventful CYGX
PPS could dip down into the low $0.40s. In any case CYGX is an excellent speculative buy. Imagine owning a part of something that could potentially change the way conditions are treated.
This is all just my humble opinion. Scooby is definitely
VERY optimistic as well he should be, but time frames when all of this will happen are anyones guess right now. Patience will be the key.
CD_98
Sometimes having bashers such as Larry and Arnold are a good thing to have on a board. One can disregard them or read their tripe. Have not been on one board yet with the exception of the Wave Systems IHUB board run by Snackman where there have not been bashers of one sort or another.
Sometimes they can be entertaining.
CYGX seems to be getting itself together IMHO. It will take time, but time is what I have to give it.
CD_98
Listened to Frank, and he is okay but not as good as Malcolm.
He failed to go into very much detail as to why toxins released from gram negative bacterias kill and how these toxins are released by the bacteria. Would not have taken
that much time to explain, plus the fact that he was much too slow to explain why ssDNA expression has advantages over other means of treatment. IMO Malcolm gives a great deal of detail and explaination in a short period of time.
And for Larry's information: again Frank reiterated the FACT that these are preclinical trials.
Looking for the price to drift down. Not too much support here
so buying opportunities may be presenting themselves soon.
JMO
CD_98
Listened to Frank, and he is okay but not as good as Malcolm.
He failed to go into very much detail as to why toxins released from gram negative bacterias kill and how these toxins are released by the bacteria. Would not have taken
that much time to explain, plus the fact that he was much too slow to explain why ssDNA expression has advantages over other means of treatment. IMO Malcolm gives a great deal of detail and explaination in a short period of time.
And for Larry's information: again Frank reiterated the FACT that these are preclinical trials.
Looking for the price to drift down. Not too much support here
so buying opportunities may be presenting themselves soon.
JMO
CD_98
Listened to Frank, and he is okay but not as good as Malcolm.
He failed to go into very much detail as to why toxins released from gram negative bacterias kill and how these toxins are released by the bacteria. Would not have taken
that much time to explain, plus the fact that he was much too slow to explain why ssDNA expression has advantages over other means of treatment. IMO Malcolm gives a great deal of detail and explaination in a short period of time.
And for Larry's information: again Frank reiterated the FACT that these are preclinical trials.
Looking for the price to drift down. Not too much support here
so buying opportunities may be presenting themselves soon.
JMO
CD_98
And gimble is right. Call the company to confirm. This should be part of ones DD.
Problem with a message board is that one must give the benefit of the doubt to the poster unless it is a blatant stretch of the truth.
Besides, this message board would find out soon enough if someone were lying, therefore I think it is safe to say
that gimblelimit is more than likely telling the truth.
Anyone finding out any different should post it.
Dear vtag,
As you have found out for yourself it is nearly impossible
to get any information on Phenuel or David Lane. The internet is a vast resource, but nearly zippo on any information.
Be patient. This is no scam. Herpes cream DOES exist and IS
going to be tested to the fullest extent on humans.
As for David Lane, rumor has it he is kin to Lois......
CD_98
8, but they are a group of well-endowed investors.
The one thing scientists do is that they often wear blinders by falling in love with a technology they are keen on, and sometimes this can work against them.
Keeping it real.......
CD_98
May I remind everyone that 4 years ago EVERYTHING was over inflated. Many OTCbb stocks were worth DOLLARS, not pennies.
Also, to increase the number of shares outstanding unless it is absolutely needed is absurd because of the dilution involved. This stock already has a moderately high float IMO.
Keeping it real......
CD_98
Scooby's predictions may someday come true but this will take time. Much to be done yet.
HIV is much more complex and adaptive. Would be interesting if CYTOs tech was ever licensed to a biopharma doing R&D on HIV. That could someday be a reality.
Sorry, meant to post this Guidance for Fast Tracking
by the FDA.
Here is the URL:
http://www.fda.gov/cder/guidance/2112fnl.pdf
Better yet go to this FDA url foe a fast track overview:
http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm
Please go to http://www.fda.gov/cdrh/index.html
This is the FDA homepage folks. Punch in "fast track status"
for the search.
under the url you will find some information explaining some of what is needed for fast tracking status.
One does NOT just submit something without some proofs from data
collected during studies done on animals and get this type of status. Even candidates that have gone through extensive human clinicals may have a hard time getting this status.
This "fast track ststus also takes TIME.
Take a look at some of the deep pockets here folks!
It takes MONEY$$$ and lots of it too.
http://www.accessdata.fda.gov/scripts/cder/onctools/Accel.cfm
Bottomline: CYGX may (will probably) come out with more promising news, BUT this is NOT a short term rocket to the moon.
This WILL take time IMO.
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 316--ORPHAN DRUGS
Subpart C--Designation of an Orphan Drug
Sec. 316.20 Content and format of a request for orphan-drug designation.
(a) A sponsor that submits a request for orphan-drug designation of
a drug for a specified rare disease or condition shall submit each
request in the form
and containing the information required in paragraph (b) of this
section. A sponsor may request orphan-drug designation of a previously
unapproved drug, or of a new orphan indication for an already marketed
drug. In addition, a sponsor of a drug that is otherwise the same drug
as an already approved orphan drug may seek and obtain orphan-drug
designation for the subsequent drug for the same rare disease or
condition if it can present a plausible hypothesis that its drug may be
clinically superior to the first drug. More than one sponsor may receive
orphan-drug designation of the same drug for the same rare disease or
condition, but each sponsor seeking orphan-drug designation must file a
complete request for designation as provided in paragraph (b) of this
section.
(b) A sponsor shall submit two copies of a completed, dated, and
signed request for designation that contains the following:
(1) A statement that the sponsor requests orphan-drug designation
for a rare disease or condition, which shall be identified with
specificity.
(2) The name and address of the sponsor; the name of the sponsor`s
primary contact person and/or resident agent including title, address,
and telephone number; the generic and trade name, if any, of the drug or
drug product; and the name and address of the source of the drug if it
is not manufactured by the sponsor.
(3) A description of the rare disease or condition for which the
drug is being or will be investigated, the proposed indication or
indications for use of the drug, and the reasons why such therapy is
needed.
(4) A description of the drug and a discussion of the scientific
rationale for the use of the drug for the rare disease or condition,
including all data from nonclinical laboratory studies, clinical
investigations, and other relevant data that are available to the
sponsor, whether positive, negative, or inconclusive. Copies of
pertinent unpublished and published papers are also required.
(5) Where the sponsor of a drug that is otherwise the same drug as
an already-approved orphan drug seeks orphan-drug designation for the
subsequent drug for the same rare disease or condition, an explanation
of why the proposed variation may be clinically superior to the first
drug.
(6) Where a drug is under development for only a subset of persons
with a particular disease or condition, a demonstration that the subset
is medically plausible.
(7) A summary of the regulatory status and marketing history of the
drug in the United States and in foreign countries, e.g., IND and
marketing application status and dispositions, what uses are under
investigation and in what countries; for what indication is the drug
approved in foreign countries; what adverse regulatory actions have been
taken against the drug in any country.
(8) Documentation, with appended authoritative references, to
demonstrate that:
(i) The disease or condition for which the drug is intended affects
fewer than 200,000 people in the United States or, if the drug is a
vaccine, diagnostic drug, or preventive drug, the persons to whom the
drug will be administered in the United States are fewer than 200,000
per year as specified in Sec. 316.21(b), or
(ii) For a drug intended for diseases or conditions affecting
200,000 or more people, or for a vaccine, diagnostic drug, or preventive
drug to be administered to 200,000 or more persons per year in the
United States, there is no reasonable expectation that costs of research
and development of the drug for the indication can be recovered by sales
of the drug in the United States as specified in Sec. 316.21(c).
(9) A statement as to whether the sponsor submitting the request is
the real party in interest of the development and the intended or actual
production and sales of the product.
(c) Any of the information previously provided by the sponsor to FDA
under subpart B of this part may be referenced by specific page or
location if it duplicates information required elsewhere in this
section.
BUT what Thalio does not say, probably figuring it is common knowledge, is that a treatment that works for animals is not at all to say that the FDA will just skip Human phase clinicals.
Even to gather enough clout or proof in the pudding for the FDA to consider a candidate for orphan drug status will take TIME and HUMAN testing of some sort.
Keeping it real........
Just remember eightball: "The teacher in 6th grade should have talked you into staying in school, what a shame."
Guess that means you figured him out too.
Forget about trying to get scooby doobie to cite one solid source other than the fact that that he has unbridaled enthusiasm. Same can be said for Larry and OKeefer. As bashers they won't divulge anything either. One can call the company but they will only tell you so much. Duh! So that must mean scooby doobie works in the lab and violates SEC regs???? Hhmmmmm
Or is he just huffing and puffing?
Is there a pattern here between scooby and the bashers?
You be the judge.
Really looking forward to the next couple of months. Fingers are watering on the keyboard........
The time is near.
CD_98
That's right scooby. Let them stay on Valtrex and support GSK
while they can. Larry doesn't believe this tech works. Maybe he works for GSK? Thinks its all smoke and mirrors so I say let him and his pop a Valtrex every day whenever the need arises, then when CYGX does market its topical that does virtually eliminate Herpes let Larry (and familia) come crawling back like the snake he is.
Maybe Larry would have to take a trip to India with his family. What is the current rate? 1 in 3 people have genital herpes? So there is a reasonable chance....
BTW scooby doobie, I like your optimism but you are years off
the mark no matter what "they" have going on.
Are you sure you aren't a schill?
This summer.... huh? Okay, I'll be watching. The time is near.
To the window............
CD_98
Isn't Dell the computer company Howard?
And Dick Wadd??? I thought it was Dick Cheney.....
Too bad about the surgery. You know, when the Colon
was left out of the operation. Con-dahh-sleaza was exposed on deFace The Nation this past Sunday Howard. And scooby continues to pump.
LMFAO!!!
Better yet Howard, we'll let YOU go into Iraq and play Rambo.
Do it for Daddy.
A more intelligent post scoobster? You?
I am sure Doc is enlightened. As you know
Doc_4_now was just trying to point out that the mice trials were fine, but that they REALLY do not count until the trials go to HUMANS. Does it irritate you when folks tell you "when trials go to humans"? Is it because of the timeline involved Scoob? How is that unintelligent? Seems to be a logical deduction IMO. But you already know it is, right?
Keep huffin and puffin. Pump this baby up Scoobster.
One would almost think you were a paid schill the way you pump away.
Keep listening to scoobsters HYPE. This IS a LONGTERM HOLD.
Looking for the next TASR better find a much lower float, and something that is very close to actually putting a product OUT on the market that is proven to be SAFE and EFFECTIVE on humans. As of now to my knowledge CYGX has not performed such studies. Right? So.....
Still much work to be done at CYGX before they can even begin to think about an FDA approval Howard.
Scooby may be just that uninformed as he seems to be. He sure seems it.
To put it another way, if he indeed is in the KNOW about certain things I am SURE the company HAS NOT disclosed to the public, which I truly doubt he/she is, then that IS a violation of SEC regs. I am sure he/she is just playing the guessing game, but in the world of bio/pharmas the timelines are elongated like Stretch Armstrong. Things take TIME.
$100 by this time next year. Yeah, whatever you choose to believe. Get a prescription for some lithium while your at it.
Jot this post of mine down and see if CYGX is even close to
$3 let alone $100 by this time next year.
This is a LONGTERM HOLD Howard, not a year, maybe two or three or four, like it or not....
Paint me a basher, I love it!
Seedy_98 )))))))))))))
Hi chi-master. Long time since we saw you post.
Here to raise doubt again I see. This time it will be a bit harder to do since CYGX has risen from the </= $0.05 level.
They have much more going on now. LW's compensation could get things started in that direction. I just put you on ignore though.
You are an interesting character.
Tah Tahh
CD_98
As of NOW CYGX has NO products even close to HUMAN clinical trials scoobster. Your friend at Pfizer should begin to school you my friend. Clinicals in India/China have yet to start with topical cream for herpes. That will be at least a year or two in itself. Sepsis will be further out than that
IMO.
Your constant posts of "we are near" aren't even remotely
close to the truth.
BTW, your friend at Pfizer should already know about VITX, however, a conflict of interest should prevent him/her from
disclosing anything Pfizer MAY be pursuing.
Keeping it real.......
CD_98
Tex, in some cases YES. 8->10 years is NOT pout of the question when bringing a new drug through Phase trials.
This is why it takes some BIG BUCKS to get candidates all the way through an NDA. Scooby doo, did you ask someone at a AZN
or PFE how much money they spend per year on NDAs and how many NDAs they put forth per year and how much they cost when all is said and done?
Another thing, does not matter if the technology is old or new
it still takes roughly the same amount of time and money. As a
matter of fact the newer technologies may be subjected to
even more scrutiny by the FDA just because they are in uncharted waters so to speak.
This is NOT a short term play. It is LONG TERM. Plan on a nice retirement with this one in your account IF all works out well. This play is not without risk, counter to what scoob says. Keeping it real folks.
CD_98
LONG
Don't work in the mail room Scooby. Maybe that's where your source is. Furthermore do you have ANY clue as to how much an NDA runs? Moneywise? Do you know how much money companies like Astra Zeneca spend on an individual NDA? How many NDA's they have per year? How much $$$$ we are talking about per NDA???
ANY semblance of a clue? Any inkling?
Thought not.
Tell you what my friend, your ignorance in this sector is without question pretty bad. Try to find a contact in the pharmaceutical business that has some years of experience who is familiar with how the process works.
Your posts are dillusional at best. You have ZERO idea of what it takes to bring an NDA to market. NONE, ZERO, ZILCH, SQUAT!!!!
DO some due dilligence on the process before you play on people's greed. Okay wise guy?
And you ARE a PUMPER dude. Plain and simple as that.
Gotcha.....
CD_98
Scooby....
You asked: Does anyone here think that after humans get this & it works we are going to have years of testing? Malcolm will have a NDA filed within weeks of that happening.
To answer your question quite bluntly YES! The NDA if filed will have NO bearing on how quickly a drug is approved. NONE.
Nada. Zilch.
All the NDA will mean is that CYGX will have to partner will
a company(ies) with very deep pockets in order to take the candidate through all phase trials.
ANOTHER THING! How can you people compare a TASER company with a bio/pharma company? There is NO comparison here. We are talking apples and potatoes here.
Is there ANYONE on this baord that has an understanding of
how long this process is?
Please contact someone you know that works for a pharma or that knows something about the regulatory side of the biz.
It is NOT as simple or short a time period as Scooby thinks it is. Don't know where you get your info Scooby, but I work in this biz. Everyone I have talked to has a different timeline in mind than yours. Maybe they and I are cracked.
This is not a short term investment folks. 2 years is kind of quick IMHO.
It is also impossible to tell just what the price will be a year from now.
If $100/share I will be out and back in after the substantial drop........ but realistically I doubt CYGX will break $3/share.
Later
CD_98
WRONG. If it is going to the FDA as a new drug APPLICATION
it is NOT "ready". That is only a first step. MUCH to still be done time and MONEY wise.
Keep it real
CD_98
Seems I thought INACTINE was a systemic cleanser. I was WRONG!
Nothing to do with pathogen elimination within the human body.
This molecule can be synthesized efficiently in abundant quantities to meet the world's need for safer blood transfusions. Vitex is unique in being the only company to have peer-reviewed publications in the field of pathogen inactivation. Further, only the INACTINE™ system combines pathogen reduction with red cell purification. By purifying the red cells during the automated washing process to remove the INACTINE™ PEN110 to trace levels, the INACTINE™ red cell concentrates appear to have achieved an outstanding safety profile.
SO, it seems as though CYGX may be in the sepsis thing alone
when it comes to a biotech means of dealing with Sepsis.
Nice as ice..........
skooby, I am currently trying to find out what the hit rate is with VITX's INACTINE. A co-worker and I were talking about
INACTINE and CYGX's expression technology.
Okay, this is why I think CYGX may be more exciting than anything I have ever held. Hit rate. Yes hit rate.
Lets asy that INACTINE has a 60% hit rate (which is probably
much better than it really is, I don't know) and that INACTINE is able to take care of some pathogens in the blood stream, BUT not all.
As I recall CytoGenix had close to a 95% or better hit rate. To add more fuel to the fire ssDNA expression will cover a VAST spectrum of pathogens (gram negative bacteria the most currentlt focused on).
Just for the heck of it go to VITX and check out their
volume. The price has not moved much, but the volume about says it all with respect to the excitement INACTINE has created in becomeing a "blood cleansing" treatment.
Just imagine what will eventually happen if/when CYGX gets
to a similar position with Sepsis. Even Herpes will be huge.
Best to you and yours skoob!
CD_98
P.S.-> As you can tell I am somewhat excited...... )))))
Good one el Capty-tan! Even got me!
Thought why would ANYONE bail out on Cytogenix now?
Who knows, CYGX may not dip below $0.60 even with weak support it could hang at this level for quite a while.
CD_98
This WILL NOT happen in just year, a new sepsis drug, and I would be extremely surprised if CYGX were $100 a year from now.
For those of you new to this company, it is a start up with very promising technology. Do your due dilligence and invest with your head not your greed.
Although things look very promising it will take more than a year to get any candidates to a validated drug stage for use by the public. Stock price may go up some on speculation, but $100/share in a year from now? If that happens I will be cashing out most of my holdings a very happy man.
This is a long term play IMO. The story is being told, and MANY chapters yet to go. The drug industry is not as quick as some would love to believe. Things take time and plenty of money.
Maybe two to three years from now we will all start to really smile. JMHO.
The time part: I thught Phenuel would have announced the onset of those Herpes trials in India by now. Bottomline: things take time due to whatever.
Scooby, your heart is on the right place. I want to retire
ASAP. If your post turns out to be right then I will be retired by this time next year.
Highly unlikely....
CD_98
The reason why there was such a shortage of flu vaccine this past year was because the largest manufacturer of flu vaccine.
Wyeth, had shut its own facility down because of persistant
problems with cGMP and numerous warnings from guess who? ...... the FDA.
Wyeth made 80% of flu vaccine out there prior to shutting its own facility down.
Archinla, as I posted that I think those wildly divergant guesses have been narrowed down to HANUMAN's post. It was my supervisor who was wrong with the $5-$10 million figure. That does seem awefully inexpensive given the amount of testing and assurances that must be done.
I am almost certain that a guy with 30 years in the biz, the former COO of a small biotech, and some pretty substantial
contacts in the pharmaceutical business would tend to have a better idea of what it take to get a drug from screening through all phases of human clinicals. $300-$500 million sounds about right the more I think about it. Being that some of the studies are done at universities the amount of money needed may not be up to the $500 million. Another thing to consider, particularly with Herpes, is that those studies will be done in India and China which will be substantially cheaper.
Still minimal resistance down to $0.41. Moderate resistance
to $0.86.
CYGX could slide. Looking for a buying opportunity, hope it does.
Thanks HANUMAN. When this guy told me clinical phase III trials sometimes involve 10000 people or more $500 million didn't seem out of the question. My supervisor was probably referring to early preliminary screening and testing of drug candidates.
One other thing this guy did make me aware of is the agressive nature and business envornment the large pharmas work in where two different large pharmas/medical device companies did hostile takeovers of two of the companies he worked for.
It's dog eat dog......
neo, as the gentleman told me yesterday, sometimes scientists
get tunnel vision and often fall in love with the technology they are working with. I told him that he had just reminded me of the stock market and how some folks react the same way by falling in love with a particular stock. LOL!
Thalio, HANUMAN, Hogger or anyone familiar with NDAs and their cost.
Just attended a cGMP training last night. The trainer
had some 30 years in the medical device/pharmaceutical
business, was a COO of a small biotech in New England area, and had a PhD in microbiology. He is retired and consults on the side with a number of pharma companies. I do not know if he was trying to make a point about the seriousness of the pharmaceutical business or whether his figures were just plain over-exaggerated, but he stated that on the average, pharmaceutical companies, like say Pfizer, spend $300 to $500 million per NDA.
Now my supervisor was there too, and he told me he worked for a bio-pharma company (his previous job) that spent anywhere from $5 to $10 million per NDA, and said that this trainer gave figures that were way over blown.
If the trainer is right, then Cytogenix will have to find a partner with deep pockets, like a Pfizer or J&J. If my supervisor is right then Cytogenix will be set if/when they get funding.
This trainer was familiar with Cytogenix, so it is NOT like
the story isn't being told contrary to what some believe.
Told me that what generally happens is that once a developemental company like CYGX hooks up with a large partner
like Amgen, Pfizer, or J&J then the stock price starts to take off.
Wanted to talk to him more about CYGX, but never got the opportunity again.
Any feedback on this will be appreciated.
TIA
CD_98