George- The discrepancy from previous dox trials is discussed in the JAMA publication. The phase 3 study confirms the data, yes not statistically significant overall, population yet an improvement over 4 different treatments...doctor's choice. Additionally, the phase 2 study exhibited 1) Overall Survival benefit 2) no cardiac risk. Phase 3 confirms cardiac risk profile and efficacy in the most important cohorts= A) 2 of the most common types of sarcoma and B) North America, Canada Australia- 3/4ths of the patient population. I made this point before: ratfacestein implied the phase 2 data was corrupted, biased to show aldox efficacy vs. SOC because it was conducted primarily in Eastern Europe and Russia. So which is it now? North America is corrupt and Russia and Eastern Europe the vanguard of truth in clinical trials? Regardless of aldox's not statistically significant conclusion in phase 3, it certainly is at least as good as 4 different protocols with ZERO cardiac toxicity. FDA will approve based on the phase 3 study based on the safety profile alone. Regarding the low response rate for doxorubicin that we observed, published response rates (investigator assessment using World Health Organization criteria22 or RECIST 1.023) for first-line, single-agent doxorubicin (70, 75, or 80 mg/m2) for advanced soft-tissue sarcoma range from 9% to 27%.8,16- 18,24- 27 The investigator-assessed response rate of 5% for doxorubicin in our study is consistent with the low end of the published range. Moreover, similar rates of tumor shrinkage with doxorubicin were documented by investigator and independent assessment (44% and 41%), suggesting that the application of response criteria was not excessively discrepant.Our efficacy results were consistent with those of a phase 3 study of doxorubicin plus ifosfamide vs doxorubicin as first-line treatment of advanced soft-tissue sarcoma.8 By investigator assessment, median PFS was 7.4 months with doxorubicin plus ifosfamide and 4.6 months with doxorubicin, median OS was 14.3 and 12.8 months, and overall response rates were 26.4% and 13.6%, respectively. (In our study, by investigator assessment, median PFS was 8.3 months with aldoxorubicin and 4.6 months with doxorubicin, median OS was 15.8 and 14.3 months, and overall response rates were 23% and 5%, respectively.)
The bashers here keep bringing up a reverse split as though it's a catastrophic event that will doom CYTR. In truth it depends completely on the accompanying circumstances.
If a company's stock has been sliding due to trial failures, with no positive news on the horizon, and they reverse split out of desperation to keep from being delisted, then sure. Shorts will see the weakness and will pile on to drive the share price back down to where it was, and without taking too much risk.
If on the other hand a stock has good catalysts approaching and has positive momentum, then a reverse split is taken as a desirable event that removes the uncertainty of a possible delisting. It's extremely dangerous for shorts to go after a company in that situation as the stock price can gain upward speed due to investors that can't / won't buy stocks that trade for less than $1, but will after the R/S if the stock shows potential.
In the case of CYTR the stock is not down below $1 due to a lack of promise. The aldox Phase 3 trial results for STS that came out prematurely were not yet statistically significant and the market mistakenly treated it as though it was a failure. Then a private offering brought the price down to $0.42. Now though we've seen the latest STS Phase 3 trial results and they're definitely good. Good enough to get an FDA approval, especially in light of how positive the FDA pre-NDA meeting went. There are upcoming catalysts like the latest results from the combo aldox / ifosfamide STS trial which were already showing a 97% clinical benefit, and of course results from the SCLC trial. Plus there's no way to know if / when a surprise buyout or partnership agreement might come out. Shorts would be taking an extreme risk trying to bring down the price of CYTR if a R/S were even necessary.
It just isn't the doomsday scenario that bashers would like us to believe.
Hey George- you lose all credibility bashing phase 2 OS results. Here re the facts: Overall survival (OS) was assessed as a prospectively planned secondary endpoint although the trial was not powered to show a statistically significant outcome. Aldoxorubicin-treated patients demonstrated a 27 percent reduction in the risk of death compared to patients treated with doxorubicin (HR 0.73: 95% confidence interval 0.44-1.20), the current standard-of-care in this indication. In addition, aldoxorubicin-treated patients demonstrated a 41% likelihood of surviving more than 2 years, a 2-fold increase, compared to a 20% probability for doxorubicin-treated patients. Median OS was 15.8 months (95% CI, 13.1-NR) for aldoxorubicin-treated patients versus 14.3 months (95% CI, 8.6-20.6) for doxorubicin treated patients (p=0.21). For treatment-naïve patients, representing 90% of the patients in the clinical trial, median OS was 16.0 months (95% CI, 13.1-NR) for aldoxorubicin-treated patients versus 14.0 months (95% confidence interval 8.7-20.1) for doxorubicin treated patients (p=0.14).
The fact remains this is a great speculative play with huge upside potential. Let them short. The stock will shake it all out to what its true value is sometime in the next few months when there is more clarity. I don't expect it to dip below .50 by much if at all ahead of the asco.
For all you sandbaggers a Prem14a stands for preliminary filing or like a preliminary hearing the one you get in court with info setting up the rea lone, this is not a mistake this is in case their is a merger or aquisition kinda like getting all your ducks in a row, doesn't mean it will happen but anybody saying this is for a RS or filed by accident is full of #$%$, if there is a merger or aquisition they will file a Definitive filing thats built right into each form, also yes if the FDA denies the NDA you will see a RS in august but if its accepted we make a shitload of money, everything I just stated is common sense and the truth......
Wow look at these naked shorting numbers for CYTR ... over 50% of daily almost every day for last month.... who in their right mind is shorting stock under 1... even under half dollar....UNREAL
Naked Short Report, Nasdaq and NYSE Naked Short Positions, Short Selling Interest
Naked Short Report - track short selling interest on NASDAQ and NYSE STOCKS, check daily short interest, naked short data and short squeeze stock perfomance
Jonas... you come and post and post then delete all your posts... what is up with that?? You make a statement - stand by statement. Who knows if you keep your statements people will follow you just like they follow Francis... May be you get more followers than him... BTW, I like you not flip flopping like you used to do before STRONG BUY
Just received an email from DH and according to him the SCLC results are still expected to be reported this quarter.
Jonas showed up yesterday very bullish with good BO offer on table ...June... Buy all you can... next day we tank... what is up with that? Is shorty going to fill the gap at 0.45? Tomorrow is the updated short interest numbers I would like to see what happened to the 12 mil shares shorted right before the offer at 0.50
I HOPE SOME OF YOU BOUGHT THAT (PBYI) WHAT I TOLD YOU I MADE OVER 500,000 I HOPE YOU GUYS TOOK A VANTAGE OF IT I BOUGHT32.00 OUT AT70.00
Bye by DOX. Hello ALDOX. Clearly ALDOX improves the action of DOX and is much safer. This aligns perfectly with FDA goals particularly when you consider the UP-DOSE capability of ALDOX. Further, ALDOX works better against STS than the entire matrix of competitors.
Now, all eyes look toward a mid June update on SCLC results, which I expect will stun many with an excellent result.
Yes, they might have a new major investor ( likely a DOX maker) and they might have a super powerful new conjugate in June - July also. Key question, is a R/S inevitable by August 1st if they cannot improve the SP? To do so, the shorts need to take a "head wound" of almost epic proportions...
How many shares do u all have?
tien-you are now officially a pain in the @#$
Loving it! Everyone just has to be patient with this one for a little while. I like the steady climb until the monster news comes of bo/m and a, Nda. I can definitely see $4 being a possibility in the short term.
Hey Lou-many thanks for that in depth analysis. While time consuming, analysis like yours are priceless.
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.
Looks like some shorties are starting to stress a bit. Will be an interesting day I think. Hope price holds up, but dunno. I'm long.
Def 14A has been filed!
what happened did i miss something? i thought we where going to be on a steady climb