fda does not move that fast. it will take cldx 3 mths to file a complete application and the fda min of 6 mths to approve
but hey as I am long 10500 shares I hope you are right. as for options I wrote jan $45 and pocketed $2.25.. little chance its sees $47.25 by jan.
stop think I am short. as I am long a bout load.
early approval if it happens could be 1 year out.
if approval is a forgone conclusion how big an impact on the pps will this have?
"stoopider" says it all
agreed, but it needs to get thru a large PIII to get to the finish line. that to me seems a big challenge given that 14 of 18 dropped out and they could not get to 28.
what may turn this around is a few more CRs in the 14 that dropped out, which should give people hope to stay the course.
can aldox be used in GBM as off label if approved in STS 2nd line?
That's 35,000 shares. and the question stands. FDA approval will require a pivotal PIII with say 300 patients. That seems to be a huge hurdle given they could not get to 28.
so tell me what their game plan is to get to 300?
how many CRs has Rindo produced?
if patients cannot tolerate the side effects and leave this will make it very difficult to conduct a pivotal PIII trial.
bring on the Japan PT.
would be nice to see, but I doubt the FDA can move that fast given the unique nature of the request. approval with a PIII ongoing.
now have a boat load of cytr. PIII STS trial well on its way. multiple PIIs going on as well. they will need to raise more cash soon,. reminds of the good old days when cldx was unloved.
have high expectations for cytr. its simply a better delivery system for chemo agent. low risk of non fda approval.
LONG will Rindo get early approval, and if so when is that likely to be Q1 2016 or later?
how do you come to the conclusion that I am short and not long the 34500 shares I own?
you my friend are a waste of air.
I see nothing re GBM at ASCO, they would have confirmed this. question is what will drive the release of the results? another interim look or final, if final the later the better.
next news if it happens is Japan deal.
but it would be first nice to know they achieved full enrollment, i.e. 28 and are not stuck at 12.
any insights as to if they remain stuck at 12?
aldox is the real deal. FDA approval for STS will be here soon enough. between now and then allot of false starts on pps move. its just how the game is played.
Not like the CEO not to crow about such matters.
you are a clown. company is at R&D stage, what are you implying that the cash is not there?
2 CRs and counting