If your immune system has been weakened that could be the case. He was not talking about immune system in general but weakened once. Just remember that people with a HIV infection often die due to an illness that would mit harm people with an intact immune System.
OS would be attributed to something other than ict107? So if all People in the control Group die and the all the remaining patients received ICT-107 we should assume that the OS is attributed to somtehing other? What? Magic spells?
Besides an after phase II FDA meeting and updated OS data in the first half of 2014.
Because they are just a guess with several assumptions. After listening to the CC I admit that invst.smrt could be right in the end, but it was clear from the CC that the management would do anything to avoid the impression that they are doing data cherry picking.
This was a phase II study and not a phase III. Just take GALE as an example.
There still could be a conditional approval like with Avastin (which had much worse data)
with PFS of six months. Phase III results then showed a PFS Advantage of three months and NO OS benefit. In addition other recently failed trials such as cilengitide’s (Merck KGaA) CENTRIC trial (Stupp, Abstract LBA2009) showed NO PFS benefit. So why would there not be a conditionally approval for ICT-107 also?
based on 3 months PFS advantage and Zero OS benefit and showed the same in the after market Phase III. Any reason why ICT-107 would not be conditionally approved since it seems superior to Avastin? All the recently failed trials (Merck KGaA) CENTRIC trial (Stupp, Abstract LBA2009) showed NOT EVEN a PFS benefit.
If I google "Prebet T, Gore S, et al, JCO 2011 Decitabine 2nd line" and look on page 3 (graphic), I think that the "new MOS" for people who lived longer than 5 months after treatment failure would be appr. 12 months. When I compare this to the 15 months (10 months MOS + 5 months treatment gap) from the CYCC study I get an improvement of 3 months or 25%. While not so impressive like 100% in my opinion it should be enough for an AA since the drug has no serious side effects and it would be second or third line treatment.
I totally agree with you. Sprio sucks regarding acting like a real CEO. He just does not care for shareholders, he seems only interested in stuffing his own pockets with shareholders money.
Right, the data is known and would not change much. And they could and should have talked about the possibility of an AA already instead of repeating the same old #$%$ every quarter and in every presentation. No wonder that CYCC has still a market cap of under 100 Million $ when they have such a lousy CEO (even though he might be great scientist).