CTIC - Cell Therapeutics Inc. (NASDAQ)

[ramsforums]

I'm out. I don't have the confidence anymore. Instead I bought Uluru at 0,18 ppc.

For Uluru, and FDA approval/clinical trial in pipeline?

[pcstock]

I just wonder how many people bought/kept CTIC due to the bullish coverage by biomed reports and seekingalpha articles.

[ckny]

When will CTIC trading start again??? Is there still chance for FDA approval?

[amozh]

Not approved 9 - 0. Go back to penny stock again??

from gekkowire :

Alright CTIC investors, it appears the FDA has erred on the side of caution and decided not to vote for approval of Pixantrone in a 9-0 no vote. Most of the FDA’s concerns appear to center around the clinical trial size for the drug and relatively small amount of data. The trial size, which was cut short because of low patient enrollment, was a key focus of the FDA’s ODAC panel meeting. The FDA reviewers that had looked at the drug questioned the trial’s size, however Cell Therapeutics argued at the panel meeting that the trial showed efficacy.

It is a shame that the trial could not get fully enrolled, because now Pixantrone will most likely have to go through another clinical trial if Cell’s managment ever wants to garner FDA approval. The panel appeared at the meeting to believe that Pixantrone was doing something, but that the data set was just too small to approve the drug. Dr. Pazdur cut in more than one time with negative comments that steered the panel in the direction of non-approval. The FDA’s official decision date (also known as the PDUFA date) is April 23, 2010, but investors should be aware that the FDA almost always follows the Advisory panel’s vote, and when the vote is 9-0 to not approve the drug then the FDA’s decision is almost guaranteed to be not approved by way of a complete response letter.

Normally, this wouldn’t be such a drastic setback if the company had been one of the larger drug companies, but Cell Therapeutics was pretty much reliant on getting Pixantrone approved and now it appears that if they want that to happen then they will have to run another clinical trial. I wouldn’t be surprised if the FDA issues a CRL and asks the company to explicity run another clinical trial before resubmitting an application. However, that may not be easy because of their debt obligations. I don’t think this is the end of Pixantrone, I would expect the company to raise additional capital as soon as possible in the form of convertible bonds to help fund a final trial of Pixantrone. If Cell cannot get financing then it would most likely mean that they would have to sell off assets, but usually small pharma companies find a way to access to additional capital.

I was 50/50 going into the meeting, however it appears that the FDA disagreed with me. I think had Bianco finished the trial in whole, then the company would have had a much improved shot. You never know how the FDA will respond to a small sample size. The FDA’s full transcript of the meeting should be posted within a couple of weeks here. I would estimate that when trading resumes on the stock, the price will drop to .20-.30 range until Cell’s management announces their next steps forward.

On a final note, CTIC’s other drug Opaxio, has been plagued with problem after problem. So in my opinion if Cell is to move forward then it would have to be with more data on Pixantrone. Cell’s management in retrospect should have let the trial enroll fully and not cut it short due to low patient enrollment.

[pumpkinchewy]

The FDA advisory panel met today (3/22/10) and recommended against approval of Pixantrone. The study was discontinued early without FDA approval and there are numerous faults found in the study.

[maritska]

For Uluru, and FDA approval/clinical trial in pipeline?

Not that I know of,got in after reading a lot on the dutch fora but to be honest I already sold for the same price. I got cold feet

[rhedayi]

I had 3 orders in one at 7 cents, one at 10 cents and one at 15 cents....piked up 5k shares at 14 cents....sold for 45 cents already - this was a bad day for longs....

[Docreech15]

I had 3 orders in one at 7 cents, one at 10 cents and one at 15 cents....piked up 5k shares at 14 cents....sold for 45 cents already - this was a bad day for longs....

Wow!! I took my attention off CTIC after the review, regretting that now

I just wonder how many people bought/kept CTIC due to the bullish coverage by biomed reports and seekingalpha articles.

I was one...but in my defense I got in at .14 and took profit at 2.23 but I held some for 4/23...so I wouldn't count it as a total loss

[nitamba]

Cell Therapeutics, Inc. (CTI) has withdrawn its Marketing Application for long drug, after that the panel raised concerns over the trial. reuters

I read this news, I know to update?

[trader321]

The FDA has not made it's final decision on this yet!! this was only the advisory panels recomedation. Although The FDA usally follows the the advisory panel's recommendation, they do not have to follow it. CTIC still has time to answer or adress any questions on the trial, which may sway the FDA's decision on April 23rd.
am I off in left field with this outlook, or is there anyone else that may see things the same way?
I made some with this, but I am still in long on CTIC.