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thanks for the dates. i have biomedreports fda calendar too. so if anyone wants to know a date, send me a message.
I am undecided about them. They maybe a good side play. But long term, I dont believe they are worth the cash(for now).
They have very little in terms of cash and tangible assets. They also own very FEW patents / intellectual property in the RNAi space. This is important in terms of licensing.
RXII is the king of RNAi; Craig Mello, the Nobel discoverer of RNAi, sits on their Board. RXII also has a lot of CASH and is about to land a big pharma PARTNERSHIP.
I would imagine they will have licensing in place ASAP(1-2 months max). they want cash to fund Generx and Excellarate, which could bring in a lot more money.
That is a great question. There are no safety concerns and they have shown very good response rates. This product can be used for things other than diabetic foot ulcers; it is a general wound healing product.
I would say there is about a 5% of no approval. The only problem would be some sort of manufacturing issue.
Just wait till the market see Excellarate(sort of like super Excellagen, but it will require an Phase 3 + NDA) and Generx(reducing heart disease)(see link).
collagen matrix == Excellagen
"The Phase 2b Matrix clinical study was not powered to nor did it differentiate between the relative contributions of the individual Ad5PDGF-B and collagen components that make up Excellarate – but both the Excellarate and the collagen matrix study arms showed substantial improvements in achieving wound closure as compared to standard of care, which is the FDA- accepted control considered appropriate for product registration studies.
Approximately 45% of patients receiving the collagen (Excellagen) matrix in the Phase 2b study had complete wound closure by 12 weeks, compared to a 31% wound closure rate for the standard of care group."
www.cardiumthx.com/generx.html
they are currently seeking a partnership ( see url ). i can't imagine they are looking to be outright bought out, but you never know. they also own a HUGE number of patents/IP related to RNAi. the attached url explains this too.
if you are interested in them, I would also look into CYTR since they own 39% of RXII. so if RXII does well, so does CYTR :)
you could double dip profits.
insert-text-here
it should being falling further. CTIC has zero value. They will be outright rejected by the FDA on 4/23. No drug company has ever gotten approval after a 0-9 vote against the drug.
They only finished half the study. Biancos are headed to jail and bankruptcy court. 8 class action lawsuits based on current headlines with more to come. If you don't tell your investors you finished the study with 1/2 as many required patients and violate your SPA, you deserve to go to jail.
sorry about the posts, weird internet connection.
my apologies
we are at day 109 people!
FDA has been averaging near 113 days for 510(k) applications.
Get ready for the rocket.
yea once it is able to trade, it is going to plummet big time. A vote of 9-0 for no approval is a death sentence. I would expect bankruptcy at some point.
I am also happy to hear a lot of the big banks own a lot of their stock; screw those guys.
IMO, shareholders will be fine. Approval should be coming this week. Then when they announce a licensing agreement with a big firm, we will go exponential.
FDA notice on 510k is averaging around 113 days.
we are near 107 days. good things should be coming soon.
whoever is buying them out is probably buying a lot of shares on the open market and people are too stupid and selling their shares cheap.
PEANUT BUTTER JELLY TIME!!
PEANUT BUTTER JELLY TIME!!
PEANUT BUTTER JELLY TIME!!
i love it when i get it right!!!!
yeah its starting to move. people are making calls to see it is the real deal.
what do you mean by profitable? they had a much better balance sheet and considerably more revenue than a year ago. however, their future is contingent upon approval for Excellagen and Excellarate. i think approval will happen, its just the FDA needs to send it.
approval should send them above $1.50 easy and maybe $2. they should be able to land a major licensing deal for the product given how large the market is in the US ( ~ $1.4 billion ). they are at $35 million market cap and they can probably take half the market with their product if not more, given their results and in due time.
another PR tomorrow?
any thoughts on whether we could expect another PR tomorrow morning. it would be good to have some re-assurances about the process.
@ hcotton
ya you think they would have gotten a name that is so similar.
Yea but they arent referring to another offering. With FDA approval coming, they will be able to license the hell out of it and make a lot of money.
Cardium Therapeutics reports Q4 pro-forma EPS of ($0.02) vs. pro-forma ($0.07) in the prior year's quarter; revs rose 334% to $0.18 mln (CXM)
CXM just posted a very solid financial statement. It also included a solid bit of information. It should be hard for the FDA to deny it...
"The data revealed that patients receiving Excellarate exhibited early and rapid wound healing responses as evidenced by substantial reductions in wound radius over the first several weeks following product administration, which responses were both greater and faster than those observed among patients that had received standard of care. For example, a 108% relative improvement (decrease in ulcer radius) compared to standard of care was observed over the first week following administration of Excellarate, and a 50% relative improvement was observed as an average over the first four weeks."
i dont know about that long. the average response time has been near 110 days. but lets hope it isnt that long.
Generx is their cardiac drug. not GNBT.
cool. i think they are a strong company and this is a less risky FDA play than most. the FDA needs to get their act together; if you say 90 days, stick to it.
i am also excited by the prospects of Generx. that could be the HUGE money maker.
anyone following CXM?
news will hit anytime now.
it was a necessity. how else do they ramp up manufacturing for Excellagen and Excellarate? they are about to take over the DFU market, which is around $1.4+ billion.
sure it could have been more favorable for the o/s. i would have been more comfortable with each Unit being only 5 shares of common stock as opposed to 10.
but i think they will deliver and approval seems pretty likely(~95%). remember this is a 510(k). i think it is a great deal given it is such low risk. we dont have to worry about side effects and whether efficacy was shown, like with oncology. it was a 55% improvement over the standard care.
oh yeah! could be a tell?
it just came and it isn't good news.
http://finance.yahoo.com/news/ADVENTRX-Receives-Refuse-to-prnews-815147953.html?x=0&.v=1
ANX and CXM
hows is everyone feeling? any guesses on what day the PR drops?
My guess
ANX - Thursday AM
CXM - Wednesday PM
CRXX anybody?
what's everyones take on this?
Biotechs I am currently following(holding):
CXM ANX CYCC
ADXS ACTC RXII
CYTR BMOD NWCI
AEN SNSS CYCC
They have a good pipeline, but they are managed by some idiots, the Flavins. Don't buy IMO or only get what you are willing to forget about for 1-2 years.
They want the shareholders to up the amount of available shares allowable to 500-600 million.