Replies to post #3786 on Talon Therapeutics Inc (fka TLON)

[lockednready]

Yes, anything can happen...depends on how much time you have will also determine your current stress level.

I've learn never put a time limit on a stock...use to make me sell too early.

Lastly, I wouldn't be surprised to see a retest of the previous low (retracements happens all the time) if we do not hear anything soon.

[Bangkok Bob]

That question is literally the only one I have been considering for several days now concerning the FDA..so, I have been thinking about this list


1 Speicialty:biostatistics
Vote: No Main concern: Statistics issue and Phase III feasibility issue
2 biostatistics No Statistics
3 Breast cancer No
4 Pediatric solid tumor No PK data and toxicity
5 Gynecologic Oncology abstain Feasibility of phase III trial Will vote yes, if FDA links the approval to whether the Phase III meets the milestone in someday
6 Consumer representative (breast cancer action) abstain Could not make a decision. Would like to see phase III data Did not ask questions during the ODAC meeting
7 Oncologist, cancer genetics Yes
8 Hematologic oncology Yes
9 Hematologic oncology Yes
10 Hematologic oncology( ALL specialist) Yes
11 Hematologic oncology (ALL specialist) Yes
12 Oncology (Solid tumor) Yes
13 Patient representative
(hematologic malignancies) Yes


On the 4 no votes 2 of them were bio statistics experts..I don't have their comments, but as they are not specifically involved in this particular field of cancer, Im not going to concern myself with them at this time...one breast cancer specialist said no , however not a blood cancer specialist..one doc from pediatrics said no...perhaps bring that doc back when the trial they are doing is specifically for pediatrics coming up later..

And finally one oncology doc abstained but would change to yes possibly with phase 3 results in...same with consumer rep (breast cancer)

Then, you have 6 oncology docs along with a patient representative dealing specifically with hematologic malignancies all voting yes..

So, considering the late stage of cancer the would be recipients of
Marqibo are, as the one oncology doc stated, the bar the FDA has to jump over for approval is low...

I think the FDA has nothing to lose here by making Marqibo available to the public while having TLON continue to complete phase 3...a possible 2000 recipients could receive this drug, who all are in late stage cancer closing in on death..

I saw some correspondence from Craig Carlson CFO that said they are optimistic about approval for Marqibo. I take particular note on the use of the word optimistic as opposed to hopeful..big difference in my mind between the usage of the two words.

I'm rolling the dice here once again that the odds are stacked in favor of approval at about 80% for a yes decision ..

Good luck to all here..

[errett]

ruflair---I suppose the FDA could delay their ultimate decision until the results of the Ph. III trial are available. I would think that they would do a risk/benefit analysis, and that they would probably approve the drug now because of the dire straits of the patients. They could always rescind their approval at some later date based on more data. The likely mortality of the patients for whom this drug is being considered is the best argument for approving it immediately. JMHO