Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
They haven't sent in an application for breakthrough yet. That will happen once they have data (p1)they can send in with the application. Depending on the findings in PI that will determine if they apply before PII. If the findings in PI show tumor shrinkage or meet other requirements set forth in the breakthrough guideline, I would expect a meeting with the FDA before applying so as to clarify and guide on what is needed in the application. BK or anyone else can chime in if this is not the process...but I believe it is.
Stats on how many applications/acceptance/denials there have been for breakthrough designation...
http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm341027.htm
Cabel...Good read on qualifications
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
From looking at PI I think it has a good chance. I hope we get a little run up so I can sell a few but let most ride.
GLTY
Very odd indeed...well the clock is ticking. I think it should start climbing as we only have 3-4 weeks until I think we see the data. What's your thoughts on the data? Probability of positive or negative?
La Jolla Pharmaceutical Company Announces Final Dosing in Phase 2 Clinical Trial of GCS-100 in Chronic Kidney Disease
http://finance.yahoo.com/news/la-jolla-pharmaceutical-company-announces-130000137.html
Thanks!! Hoping to have new funds in the acct tomorrow so will take a position first of the week!!
ADMP....are there near term catalyst that would result in this starting to move swiftly? TIA
I see the value but unsure on timelines!
Buyout $100 per share....??
(J/k) maybe one day down the road...once K proves itself $100 could be a low valuation if the other drugs prove to be successful too!
Started my position here today. Should have been in this 2 months ago but would have had to alter my investments which I don't like to do before my goals are attained for that investment. Looking to add more but will do so slowly and on dips! I appreciate everyone's insight on the board as the posts have been very informative and made doing my DD easier to start with!
GLA
Good deal! Thanks for the clarity!
They have actually raised requirements to 250 on trigs....
Roger that! I will give it a shot on the PC this evening. Preciate the insight!
I was actually using my cell. So safari is the browser.
Maybe I should try to view it from my PC this go around? Is that your suggestion?
The 60 days begins once the company submits all necessary documentation to the FDA. If they get breakthrough designation then PIII will not be necessary. I think a post marketing study will be asked but the sooner to the market means the company starts producing revs quicker. This alone is going to drive price and speculation of imminent partnerships/buyout will occur because of the FDA stamp of approval. I'm not going to put a price on what this will bring as far as the sp but I would imagine it will jump and trend up if we get BTD. Definitely into double digits...it also depends on the exact requirements the FDA will give with their response. The company stated they would submitted all documentation before the end of the quarter but I think I read they will not PR when they send it in. So no exact date response will be able to be established.
GL
Maybe I just didn't give it time to load last night! I tried that link and then had the notion that was a link for the live webcast and it was not the archived link. Will listen later tonight. Thanks for not making fun of me....haha.. ;)
I wonder of these other lipid and anti-inflammatory parameters are going to be established as a baseline upon a patient enrolling in the REDUCE-IT study? Do you know the answer?
If you don't I will check with someone who does....Let me know!
Anyone listen to the webcast? Couldn't find it archived anywhere so if anyone has a link that would be helpful!
Thanks Buc for posting this info!
How often does the compassionate use info on the website get updated? I see that 78 patients have participated but do not know at what point in time that refers too.
Here's a drug in compassionate use program....http://www.pvct.com/compassionateuse.html
What everyone's opinion of data results? Weighted positive and negative outcome...
Thx for that chart!
Thanks for your insight. Very much appreciated...the questions were intended to promote discussion on B with varying outcomes and your descriptive response was very informative.
Thanks for the reply no retreat.
Between the single dose and the issue of non-resistance there will be no room for anyone to step into the space!!
In addition, cost being considered I imagine that a single dose will be less than daptomycin so that coupled with the no resistant nature will give great formulary access from managed care organizations. But that's all down the road!
First we wait for results!
Let's name 2 scenarios and get opinions on what the approval process would be...
1. B is shown to be Non- Inferior to D.
Do we see a phase III?
2. B is shown to be superior!
Do we see phase III?
Just curious on everyones thoughts....
Brilacidin trial info now up...not sure if anyone posted this or not but it outlines all arms and timelines
http://clinicaltrials.gov/ct2/show/NCT02052388?term=Brilacidin&rank=1
I agree that the only way B achieves the greatest potential value is based on it being "Non-Inferior".
Also I believe the MOA of B offers advantages as well. There is still a threat of resistance that has been found in multiple clinical settings for daptomycin also. Refer to links below:
http://en.m.wikipedia.org/wiki/Daptomycin ...look under the resistance tab
http://aac.asm.org/content/52/3/1167.full
http://www.nejm.org/doi/full/10.1056/NEJMoa1011138
http://m.cid.oxfordjournals.org/content/40/7/1058.long
The only reason I would disagree I because CTIX had the current valuations prior to obtaining Poly assets. It depends on if it is a clinically significant difference too. There is a unique advantage to single dose therapy over 7 day. I believe that holds value and based off of phase IIa I think it's more of a 70/30 pro brilacidin. That's IMO of course
Are you saying if it's equal to or better than daptomycin than we should see $5....
But if it's less potent than 7- day daptomycin that we should still see $1 per share increase in value?
Just want to make sure specifically what you are wanting feedback on?
Lots of red today. I have 20 stocks I have on watch...2 are green. Good day to add or initiate positions
IMO of course.
Thanks. I am gonna go back through a lot of filings tonight and tomorrow. Was limited on time today as I have been making rounds at Bday party's with my kids! Very exciting stuff!! Lol
Gulf were some of these shares purchased open market or were they options? I think that's kinda what Ovidius was getting at...but I agree that is a lot of skin in the game but the question is what was his entry price? If they were options I'm sure he's still up...
Nice day here!!
Then why are you on this board posting if you stay away from what you call a pump and dump company??
Interesting....
Long PVCT!
Know what you own!!!!
Did data readouts get pushed back from the dates listed on clinical trials.gov
Yes. I think we start to climb between now and Friday.
Love the new photo!!! Lol