The company should defintely pursue this indication since it seems they wont be getting plasma/platelets approved by the FDA anytime in 2014. At least it would divert shareholder attention away from the cost associated with getting all the submission data together for the FDA to review in 2013-2014.
Sentiment: Strong Sell
Holy mackeral! This is not going to end well for those long not fully hedged! End of August and not a hint of when plasma will be addressed? Do you have a sinking feeling? Id say something is very very wrong here.
I guess we no longer talk about plasma or platelet review and approval any more as 2nd half catalysts LOL
Sentiment: Strong Sell
(The current RBC kit may indeed be modified as you say for commercialization in trade dress, but that doesn't require new phase III studies since the active ingredients will be the same.)
That is not true. CERS will have to define the commercial red cell kit before it can begin P3. The FDA does not allow you to submit P3 from one kit and then use another kit for commercial use. That "same ingredients"
statement was very amusing.
Why would the FDA change for Chickunyunga and not for West Nile or Chagas? They wont change for the chikun. LOL
The dynamics of the uptake for rbcs no one can explain, not even you. The cost of switching to rbc PI would be enormous and will not be implemented quickly if it ever comes to pass. Because of the enormous added cost the political debate about risk/benefit will drag on for years. Even in France most of the platelets are not PI. In Germany the same thing, only a small percentage after 10 years? But yet you see quick and universal acceptance by major nations! Listen to the conference call? And believe all the rosey scenario garbage the management feeds you? They are supposed to be cheerleaders, their job is to sell the company. Read the scientific debates on PI versus screening/testing for more realistic views.
I will tell your right now the FDA is biased against PI versus testing, and that is going to make me a bunch of money.
Sentiment: Strong Sell
Early use does not mean FDA approval, it does not lead to any significant revenue. Phase 2 RBC data?phase 3 EU RBC data in 2014? Do you live in Denver? Smoking the weed day in and day out can cause hallucinations. Please reference and prove me wrong. They dont even have a finalized kit yet for RBC. Uptake swift? Like in EU where Intercept platelets have been used for 10 years? The UK is broke, they will not adopt PI unless the USA and Canada adopt,so that means never.
Form 4 CERUS CORP For: Aug 14 Filed by: COZADD BRUCE C
A positive sign! At least someone thinks CERS si worth $2. LOL. The Baker Bros is old news not present news, big players often load more before they dump to throw investors off the scent.
Dont hold your breath. You can lie to yourself as long as you want but dont be shocked when the FDA committee fails to review plasma this year. They most probably are waiting to announce rejection of both plasma and platelets at the same time. They have had the plasma data a long time so if they were going to approve, it already would have been done.
That was tremendous insight! LMAO. Kiss your 3.70 goodbye in another month. Oh wait, mymandon says CERS gets approval of plasma then! LMAO. You guys are clueless. Wonder what the excuses will be when the year ends and still no FDA approval/rejection? CERS ran like a bunch of Keystone Kops when asked a question about the status of plasma with the FDA.
You got it right! Looks like FDA will wait and not deny approval on plasma until they reject platelets. When will that be? No committee review date set even! Who knows maybe some time late in 2015. Meanwhile these guys are setting up their retirements. Another "story stock" used by the insiders to make a fortune. Dont be stupid, get out while you can get $3, it wont last much longer.
Unjustified negative comments? Are they unjustified. Certain posters have told us plasma approval any day now for the last 180 days. They tell us a committee review is not needed before an FDA approval. I think we all know this was not true now. Before now we thought this was some sort of minor blip, now we know this is something very sinister, very major about this delay. The likely hood now is that CERS will never get a platelet review, they may get a plasma kit rejection and that means bye bye platelets. I think just by the up-down trading range and volume that the major holders are extremely well hedged and will more probably exit sometime in the next few months at break even or plus. That huge short interest is not there by accident.
Sure, sure now the timeline for plasma approval is not important. The sterility data mean jack, this is nothing new. The question about platelets has never been about anything except function and survival. The IDE request has no bearing on approval or timeline. Try spinning this more please.
I warned you this was going to be a disaster. Watch this erode to under $3 over the next few weeks. Notice the plasma question, did you like your answer? Look for one of the major holders to lose patience with these clowns and start unwinding. How low could it go, well if the next FDA advisory committee doesnt have Intercept plasma on it for review, $1 is not out of the question.
Get out today. Thursday will be too late, Tue-Wed might be too late too! Earnings call will be a total disaster. CERS will stonewall any questions on plasma approval. This thing is making me loads of dough, I just dont wan to see anyone lose their nest egg. You have been sold a bill of goods that wont get you jack.
Also dont you get the feeling that somehting is very wrong here? Im glad im short. I see nothing but $ for the rest of 2014 and Im sure now we will see a low of less than $3. Especially since the July earnings call will be nothing short of brutal!
Im glad you informed me of Octaplas........Im 100% certain now that Intercept plasma will be reviewed by The blood advisory committee before the FDA approves it. So it will be at least into 2015 before final approval.......Remember Octaplas was approved in Jan 2013 by the FDA. Intercept plasma is not yet on any blood product advisory committee agenda
(September 20-21, 2012
On September 20, 2012, the committee will discuss hepatitis E virus and blood transfusion safety. In the afternoon, the committee will discuss Octapharma’s biologics license application for Pooled Plasma (Human, Solvent/Detergent Treated). On September 21, 2012, the committee will discuss )
Yes you are right Octaplas was approved in 2013. It is a pooled product with a different methodology.I guess there is no market for Intercept plasma to speak of. A waste of a lot of money and time for submission. Probably should short more, when most people realize there is no revenue going to be coming CERS way for a very long time the short interst should grow exponentially.
(There is more global experience with Intercept use for plasma and there is already a pathogen inactivated plasma available in the US, so this is why they will not need a BPAC meeting for approval)
There are other methods for PI plasma used in the UK, EU, etc but please tell us who manufactures and sells PI plasma in the USA? I would like to know this since to my knowledge there is at present time no PI plasma available in the USA and licensed by the FDA. If there was PI plasma already licensed and used in the USA there would be no market for CERS to waste its time with this submission, they would just submit for platelets.
You keep saying that a committee meeting is not needed for Intercept plasma as if it was fact, but this would be unprecedented. Ive seen the FDA shoot down an approval at the last minute. Ive even seen the FDA deny approval when an advisory panel voted more than a 90% approval recommendation. Yes short and getting shorter.
You are entitled to your opinion for what little it is worth. But if its fake or BS, prove it dont just run your mouth.