The CC was a disaster, LOL. Now the entire review process for plasma and platelets are up in the air, the timeline is now someday....... we hope. LOL. Ongoing operations are seeing revenue plummet. This has short written allover it. Once we get updated ownership stats it will become clear that all the major players are dumping??
Stock keeps reaching new lows, trades up here and there but the trend is definitely lower indicating some sort of very controlled position unwinding by a major player trying not to #$%$ the market. Must be some problems with the plasma or platelet submissions? Notice also no advisory review of plasma has been scheduled. This should raise a red flag to traders.
Does not look good at all! Must be something wrong here?
Well then why have they not scheduled a meeting to advise the FDA on acceptance/rejection? There must be some serious questions that need to be resolved before the meeting? This tells me that a rejection recommendation is most likely now. Maybe they are waiting to reject platelets and plasma at the same time in 2015?
Yes, the more kits they sell the more money they lose. Without platelet approval by the FDA the company will never become profitable. Now that plasma approval seems to be delayed, platelet approval delay or outright rejection would seal the company's fate. This is now a very very big gamble at its 3.85 price.
The plasma review has little potential to do anything for the price near term. Earliest CERS could get approval ( and thats not a certainty) will be by the end of 2014 and sales arising from that wont be until sometime in 2015. The pathogen inactivated plasma market is not a large market, its for a small special patient population. CERS plasma is not going to replace regular plasma in most cases in the USA or canada.
The UK is not going to go to pathogen inactivated anything because of severe economic restraint, ask any drug company with a new more effective drug that costs more. Also there are several other methods being used for pathogen in activated in EU right now.
There is no compelling story for plasma ........ only gives the company hope they can correctly submit hemovigilance data to the FDA that the FDA can approve. So they can sell the possibility of platelet approval by the FDA in 2015-2016.
First it looks like the plasma will not be reviewed until either late this year or early next year..........thus the need to borrow $30M at a very high price with a first in line guarantee should the company go belly up. Could not sell stock because it must have been too risky for anyone to bite at the present pps. Dont forget this delay will cause further platelet delay maybe into 2016. This company looks like a BK candidate.
There is absolutely no truth to your assertion that a plasma decision will be made soon or that it will be positive. The fact that questions arose in April and CERS has not received a decision raises red flags. Your assertion that the much more complicated decision on platelets will be made in 9 months is ridiculous, its taking 9 months for a plasma decision. Platelets probably might take years. Only minor possible revenues from plasma in 2015, none from platelets. Your timeline for RBC approval is pure fiction, they dont even have the final product close to completion that is why they partnered the development to another company. There is no quarantee they will be able to produce a commercial RBC set to use for a clincial trial! The loan was the only thing they could get, no one is going to take payment in stock at this point.
Yes they are holding right now, maybe not too much longer though.............they dont hold their losers forever. Notice though the second biggest holder Fidelity bailed big time dumping all they could since their last filing. Look for CERS to slip under $4, until the Bros make a the right decision on this losing dumper...........then we could see it slip under $1 again until it goes belly up.
We already know plasma wont be until the last 3 months of this year....if then! Sure ignore the sales figures in EU we all know the company goes BK on EU sales. They havent turned a profit there ever! The plasma market is a dwarf market, very little profit to the bottom line, wont make CERS cash positive. You are right though it is the first step before it trips and takes a header. Sell now while you can get $4.......it wont last once the next big holder starts selling.
The eternal optimist, or how easy it is to lie to oneself. What makes you think the 180 day period started with the submission? All new licensed blood products (yes, all modified blood is considered to be a new blood product and is given a specific product name ) have to be reviewed first by the Blood Product Advisory Committee and a recommendation given to the FDA. The FDA then makes a final decision. Since the pathogen inactivated plasma has not be scheduled to be reviewed yet by the committee it probably will be reviewed at the last committee meeting this year in NOV/DEC. That is when the 180 period begins I believe so we are looking at Jan-June 2015.
Another thing mymandon keeps spouting is the 8.5 million shares the Bros. hold. He fails to mention that there are around 11 million shares short. You think they own any? LOL. This bet on CERS is hedged so when they pull the plug their loses will be muted. Will yours? Also the second major owner sold shares like crazy this year and reduced their ownership considerably. Red Flags.
Do you really think a decision is near? If it was near there is no way the stock loses 12% in 2 days. The evidence does not support a near term decision, more like an open ended time delay.
Whats interesting is that you treat the pending plasma and platelet approval process differently! You say plasma approval does not need a committee review but platelets do. You say anytime now on the plasma but its been like 8 months and no word at all. Then you turn around and say 9 months for the whole platelet process. You totally ignore the fact that every other blood associated product gets a committee review before being rejected/accepted by the FDA. Sure they could have sold $10M worth of stock but Im betting they would have to sell it at a 25% discount to market and had to throw in a bunch of warrants. Anyone can sell stock if its cheap enough. The dilution would have made those Bros really happy I bet. Real happy.
I wish I knew. Why did the stock fall over 12% in 2 days? Really not any convincing volume to make even an educated guess. Management here doesnt lie they just dont tell you what they know.
Sure, we know the difference between a cellular product and plasma coagulation factors. Why do you somehow think that a blood product of coagulation factors doesnt need a committee review while a cellular platelet product does? Sure they use the same kit. I think you have watched too many Wachowski Bros. movies and are hung up on matrices? They both have to satisfy the committee on safety and efficacy before the FDA makes a final decision.
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.
(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.
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.