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Indeed, even Harbinger officials say they cannot explain why Wedensky Modulation works, only that it seems to be an excellent predictor of sudden cardiac death.
Enough said. Right now the only competition for camh is its incompetent management.
nobuddy,
i am "hoping" that EMEA does not reject it but gives an approval in any shape or form. you of all people on this board should know that just becos FDA rejects a drug does not mean emea will reject it. the writing was on the wall wrt the fda;s decision. no lowering the bar even though the bar is the same for all drugs for all conditions. with the emea, my limited experience tells me that they will view orbec more objectively and consider the risk/rewards. Is patient advocacy high on their agenda? If so they will approve the drug only if they are convinced 100% the drug works. It is safe and there are signs that it is effective. Hard to say what the decision will be considering they failed the primary endpoint. If there is a precedent then chances are good for approval, if there is no precedent i doubt emea will settle for anything less than an additional trial. We will soon know within the next month or two.
"IMO you should reconsider your last thought. I am suprised that it is holding in the high teens this morning and I think in 3 months you may regret not taking 18c for it now."
People probably waiting out for decision by EMEA
Its over when EMEA rejects it,
not until then
corpstrat,
just my two cents i think the posters who were optimistic about approval were honestly optimistic. they gave good arguments for approval. There were warning signs though and posters with concerns (such as myself) were allowed to post without hinderence. Clearly the primary purpose of a message board for a stock (such as ihub) is to tout the advantages of holding a stock. In my case, I was clearly compelled to sell but greed got the better of me.
Prochymal PIII trial,
They are planning on using corticosteroids so for GI I assume it would be prednisone and not the BDP corn oil concoction.
My guess is tomorrow,
because the fda probably has its answer. Based on Prochymals pIII endpoints the FDA has made it clear what the endpoints are. The question is whether the data dorb provided proves it conclusively.
But obviously the real answer is that its anybody's guess.
acute gvhd,
my understanding is that prochymal is to be tested for gvhd that occurs inside gut and on skin. orbec is only for gut. which kind of brings down the ethics issue irrespective of whether predisnone or bdp in corn oil/orbec is used... or am i wrong?
So ethics is not an issue?
The question is, if osiris can run a pIII trial, why can't dorb? If BDP in corn is the SOC, how can a placebo controlled trial even be possible? What am I missing?
It was also approved for ovarian cancer
http://www.medicalnewstoday.com/articles/47490.php
Better comparison than genasense,
Coincidentally, if im not mistaken, Gemzar was approved for treatment ind for pancreatic cancer way back in 1994.
genasense and orbec,
I'd be interested to see what the board thinks of a comparison of these two drugs. To a layman like me, the former should have been approved for pretty much the same reasons that orbec should be approved.
Regarding your last point
"HOWEVER, Dor provided additional data to the FDA. Is the final package (two studies plus new data) enough for approval? Perhaps, but McDonald was implying that the two studies was enough ... the FDA disagrees."
I think the new data DOR provided is from the two completed trials, that was probably not provided before, for whatever reason. Were you implying that DOR got the data from some other unnamed trial? IF the data proves to be satisfactory then obviously the two studies are enough.
Pro's far outweigh the con's for orBEC
Agree with you on that. I'm not experienced enough with the FDA's dealings to comment on the politics. What i'm most concerned about is the statement made by one of the panelists which was regarding lowering the bar. Is there substantial evidence that the 50-day endpoint was flawed? If there is then orbec has a high chance of approval. If not I just don't see the FDA lowering the bar just to appear compassionate. Other companies could claim that future trials would not be ethical and use Orbec approval as a precedent. What i've seen of the FDA, which is very limited, leads me to believe that they are an extremely rigid agency with ice in their veins.
"approvable after fulfillment of additional regulatory conditions."
I'm long as well, but i don't read this as approval with conditions. I read this statement to mean a standard approvable with additional data required or an additional trial before full approval. But the release does appear to take non-approval off the table.
"Is it not best to error in favor of the patient when safety is not the issue. "
One word, provenge.
bid 0.35 ask 0.83
Anyone else see this weird behavior?
Confident PR
Kind of reminds me of the gild quarterly a few days before letaris approval by the fda. They were so smug and confident about what would be in the label and even said they would be able to show everyone the label the day after the pdufa date. lo and behold, even though the label was not what they expected, they did get approval.
EU revenue expectation is too low
Euro is almost 1.5 times that of the dollar. Even assuming a smaller GVHD population, the revenue from EU should be almost equal to US revenue or even more and result in a much higher price increase than 50 cents!
The reverse split
A reverse split is a confusing signal. Without approval of a product a reverse split will probably screw us shareholders in the short term. Only way it can help is to finance the company. With approval share price will probably go into the 2's or maybe even the 3's and then a reverse split will get the company out of the otcbb after a few months. Hard to predict what the company expects but it doesn't look like they expect to sell the company in the near future.
thought it was the investment company drbio was talking about
DVD copies
Which company sent you copies? Dorb?
treatment ind,
Would the treatment then be covered by insurance if approved under that condition?
I spoke to a gentlemen named keith thornton from dorb yesterday. Nothing really new came out of my conversation though. He stressed that the after-vote discussion had been extremely positive. He also mentioned that sigma tau was still very interested in them and talks are still ongoing. any salesforce hiring will come after approval.
dorb buyout,
that depends entirely on what the FDA wants doesn't it? I don't expect anything other than an approvable at this point from the FDA. If lucky maybe an approval. But any approvable will most likely require an additional clinical trial and everything depends on what the FDA wants from that trial.
HPA suppression
Anyone have any thoughts about DORB's statements on HPA suppression? It appears that the company's two statements contradict each other ie the placebo arm's treatment failures were not included and higher treatment failures would result in greater HPA suppression. FDA's argument is that the second statement doesn't explain why the Orbec arm had a higher HPA suppression. If FDA's claim can be disputed I think Orbec has a much, much better chance.