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01-19-2011 04:25 PM #2571
Funny enough i knew it the one thing I had an issue with the device.... shields approval. This might still get approval this year depending on how far gone the trials have been ...12 weeks (3 months + 6 months + 1 month for fda meeting to clarify the issues we are looking at october or december latest january 2012 approval. I will keep buying and buying and buying and buying till i cannot buy anymore
Last edited by Spunk; 01-19-2011 at 04:31 PM.
Cheers,
Spunk
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01-19-2011 05:30 PM #2572
Yikes!!!
Glad I played this small and protected my ball$.
Knew something was up when they didn't announce during the regular session. It would have further dragged down an already beaten down biotech index.
Can MannKind continue? Where is the trail funding coming from? Two FDA smackdowns? I haven't seen CRL details, but my goodness.
In the words of Kenny Rogers...You gotta know when to hold em...Know when to fold em...Know when to walk away, & know when to RUN.
It will be interesting to see what Al does with Mannkind from here.
GEG.
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01-19-2011 06:44 PM #2573
Make your money back. Buy VVUS Feb Calls. Meeting with FDA buy end of month. VVUS wilt go up if OREX gets approval or CRL. Buy SPPI May calls. April 29 FDA decision. Easy double on the calls. Last time in Sept 2009 SPPI went up to 8.00 before approval.
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01-20-2011 09:33 AM #2574
I was not heavily invested but i still like the CRL funny enough it makes complete sense. The timelines being given are a little outrageous if mankind have already started the trial and it needs to get tweaked then that cuts a lot of time
1) They already have their trial patient pool
2) Trial is already or should start shortly
They need a meeting with th FDA to clarify or design the trial to meet the FDA's needs and with AL ability to fund trial internationally namely in Bulgaria, Russia and co it makes for a faster response are they gonna respond to the FDA within 6- 8 months ....you heard it hear first Yes . Now with the amount of shorts covering this is headed back to 6.50 ...there are just too many shorts and not all that much shares availaible if some investors decide to hold on then shorts would have to cover.
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01-20-2011 02:00 PM #2575
Junior Member
- Rep Power
- 44
Neoprobe seems to be a stock that could potentially have some big gains in early 2011. They are expecting positive news on several fronts over the next few months and expected to announce results from their Phase 3 trial using Lymphoseek in breast cancer and melanoma.
Does anyone have any thoughts?
Thanks,
MrSpitze
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01-20-2011 03:29 PM #2576
MNKD - nice bounce today
DEPO - gaining momentum again
The biotech sector in red again today, hopefully that will present some good buying opportunties for all of us
On the radar - NEOP, VVUS, SPPI, XNPT and PLX
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01-21-2011 05:23 AM #2577
Bad week for MNKD, DEPO and biotech in general.
I do hope for some recovery in DEPO though. I still have a few february and march options, some of which I may keep through approval. I had a single MNKD option that was more a gamble than anything else, so I did lose on that one but nothing big.
Otherwise I used the current pullback to get some more SPPI, XNPT and PLX
I also entered DCTH, that one could be big.
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01-21-2011 08:07 AM #2578
Member
- Rep Power
- 69
Looks like VVUS is getting slapped in the pre-market because the FDA asked for more information on the potential for birth defects. Interesting....
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01-21-2011 10:41 AM #2579
I like VVUS manaagement cause they just flat out state as is information from the FDA, yes the new is not too good but at worst it creates a black box warning and further confirms the fact that pregnant women or women at risk of getting pregnant should not be on Qnexa......I think everyone that followed this company the past year have been expecting this to be the case. Enough said ...This new task would definately require some time to abasord and answer and I think this throws VVUS pdufa to late 2011 if they do not file by the end of march we might be lookingg at 2012 on VVUS
The FDA is extremely and i mean extremely conservative....could it be to much scrutiny. I think we need a republican in the FDA to allow more drugs through as this lady is truely sending companies packing when she could easily approve and have concurrent further trials on many of this drugs ....See how a litigacious soceity sucks!
Wow very interesting week not all second time to the dance companies are good for ones portfolio. Will mannkind gain approval the third time around yes ..if they plan the trials with the FDA and if the trial size is big enough to not be discounted ...Now their trial is actually a slap on the wrist but it has to be done I see them getting approval sometime late 2011 or late 2012. If I were them I will sit back and do it well ...not in bulgaria or russia or india ..right here in the USA or Canada .....have them have a SPA on it if possible and it has to be blinded so no more lawsuits from employees ......Then we shall see the true value of this company.
Sppi is going back to the dance will there be a run up YES to how much maybe 8 dollars ....approval when it comes to sppi causes the stock to tank ive seen this before.
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01-21-2011 05:36 PM #2580
U have to be careful with biotech run ups. U need to get in early or buy at a bottom or correction. If u would have bought MNKD in Aug or Nov and wanted to play the FDA date, u would not have lost as much or broke even. Run up method is being manipulated by big money, because they are aware of this method. Get in early or on a correction. SPPI had a correction since the high. May options are fairly priced with more interest in calls than puts.
Last edited by sofakingcool; 01-21-2011 at 05:44 PM.
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