There is no way they would do a big secondary if they thought Orafailin had a candles chance in hell. The action date is November 26, 2 weeks away. In the unlikely event that this drug was approved, then the stock would be higher and worth more.
Everyone but 5 idiots on the supergen board knows what lack of an ODAC panel means. Well over 90% of all cancer drugs go thru ODAC. Plus supergens data was terrible and they never released 2/3's of it. I could care less if anyone agrees with me. In 2 weeks whoever doesn't wake up will just get sucker punched again. What the hell, it is only money down the drain. IMHO
Stopmindless pumping and Rad wannabe MD both have this habit of telling one side of a story.
The 4.4 million shares are just registrations they committed previously to do. The other 200k is what was approved by the stock holders for the employee plan.
Many cancer drugs are approved without an ODAC. Including Pharmion's Viadza which had recommendations NOT TO APPROVE!
There are a number of reasons that Orathecin has a reasonable chance of approval. There is also has a reasonable chance of rejection or an approvable letter.
Orathecin versus best available therapy.
1) 28% versus 13% disease control, wow.
2) 22% versus 13% stable disease.
3) Time to progression is improved slightly.
4) Survival time is improved slightly.
5) Orathecin is very safe with few side effects, very comparable to supportive theraphy.
6) The fact that they kept allowing patients to crossover to Orathecin during the trial, demonstrates it works.
7) Orathecin has orphan drug status, which means there aren't good treatments.
8) This is an oral treatment, which provides advantages.
9) Four cancer drugs have been approved without ODAC. Some such as Pharmion's have some nasty stuff in their files!
10) Oncologist community is a rather sophisticated set of doctors and the FDA seems to be of the mind set to give them every possible tool with any efficacy and with reasonable safety.
11) The NDA being for an indication after another chemotheraphy has failed, means this will initially be targeted at the sickest patients where it can do no harm. The FDA may have a lower bar for this. Also this may be the result of a negotiation, like occured for Viadza. In Viadza's case the day after the agreement on an sdditional trial was signed the approval was issued.
12) Secondary endpoints did not depend on crossover, so they should be clear data.
1) Did not meet primary endpoint (survival).
2) The statistics and therefore the NDA is complex. This is caused by the patient crossover to Orathecin per the trial design.
3) Many innuendo's as to the quality of the Phase III on Orathecin and Supergen's ability to submit an acceptable NDA.
4) The FDA could view some of the data as data mining, which it opposes.
5) Only the results from one study have been released, so we don't have a complete picture.
I find it interesting that Adam F. at thestreet com has postured himself not to have egg on his face with an Orathecin approval. R&R are cautiously optimistic. There is really no reason for them to be supportive at the moment, it this were not the case, even though they have a long-term investment banking relationship.
Place the words PIPER GUIDE TO ODAC HISTORY in Google or other search engine.
business a rest! The co.,analysts and just about everyone else on earth assumes it will not get FDA approval. According to analysts this is not to affect share price. Talk about your mother your feet or even maybe the positives of this co. Get over this Orathecin bashing as it does not matter!