dd_for-me. Many here thought that Apaziquone was dead because SPPI was so weak on communications. I have high hopes for SPI-1620. It may be dead, but don't use SPPI's silence as a basis for that assumption. Time will tell. Note they also don't talk about marquibo or beleodaq, both are very much alive for further development.
Shorts get crushed only when there is a major positive SURPRISE announced. The Apaziquone NDA filing and initiation of SPI-2012 trials are expected. I doubt will they generate any squeeze. I just hope SPPI delivers these milestones this year.
If we don't get the SPA settled within the next few days, I doubt that SPPI will even be able to initiate the P-III before the EOY. Look at the delay between Apaziquone SPA PR (Aug 17th) and actual initiation of the P-III.
The Eagle deal and monetization of Zevalin-Japan are good for the company and its employees, but not what the investors need to see. We need real advancement of the pipeline and real VALIDATION of the pipeline.
I wound not be surprised if SPPI sells or out-licenses Zevalin Europe rights also. We have no real sales force to promote Zevalin or any other drug outside the US.
Irrelevant. The PPS will be driven by milestones both hit and missed. Right now few are even paying attention.
"As I have mentioned before, all it will take is for Raj to sign a marketing deal for SP-2012 in the EU for the stock to have a huge gap up. It can happen any day."
I've said this many times also and I agree, but, we must keep in mind that SPPI has never stated that they are seeking such a deal. It could happen. I hope it does, but we are flying blind on this.
I doubt that anyone has followed SPPI more closely than me over the last 10 years and no one has given Raj more benefit of the doubt.
Our PPS problem is that SPPI management has decimated their credibility. I can't count how many times SPPI has blind-sided us. I still believe in the pipeline and am still all in, but it has become a test of conviction.
CREDIBILITY is the problem. If the market just believed that Apaziquone would get approved the PPS would be double what it is now. Without credibility the street completely discounts SPI-2012 and Poziotinib. I have high hopes for SPI-1620, but SPPI has gone dark on it, so who knows what to expect.
SPPI will survive and continue to grow, but I can't say how long we common shareholders will suffer from their mistakes. I hope not too much longer.
Just trying to keep it real.
SPPI is in no position to do any buybacks of shares. Let's keep it real.
SPPI is meeting with the FDA today to get clarification regarding the CRL and what needs to be done to get it refiled and approved. Hopefully we get an update today or early next week.
Looks like Bel-CHOP (CR 72%) may be at least as good if not better than double-CHOP (The overall complete remission (CR) rate following Double-CHOP treatment was 68%). Also note at least one treatment related death from double-CHOP. That could be a show stopper for double CHOP.
Efficacy of a dose-intensified CHOP (Double-CHOP) regimen for peripheral T-cell lymphomas.
Peripheral T-cell lymphomas (PTCLs) are a rare and heterogeneous group of non-Hodgkin lymphomas, often resulting in poor prognoses. The CHOP chemotherapy regimen, which includes cyclophosphamide, doxorubicin, vincristine and prednisone, has been used previously to treat other types of lymphomas. Here, we examined the efficacy and safety of a dose-intensified CHOP regimen (Double-CHOP), which was followed by autologous stem-cell transplantation (ASCT) or high-dose methotrexate (HDMTX), in PTCL patients. Twenty-eight PTCL patients, who received 3 courses of Double-CHOP at our institution, were retrospectively studied from 1996 to 2012. Patients with anaplastic lymphoma kinase-positive anaplastic large-cell lymphoma (ALK+-ALCL) were excluded from this study. The median age of patients was 58 years (range: 17-69). They had low-intermediate (n=11), high-intermediate (n=10) or high (n=7) risk according to the International Prognostic Index (IPI). The overall complete remission (CR) rate following Double-CHOP treatment was 68%. Of the CR patients, 10 successfully tolerated a consolidated high-dose chemotherapy followed by ASCT and 7 received HDMTX. A single case of treatment-related mortality was recorded during the study. On a median 31-month follow-up, the estimated 3- or 5-year overall survival (OS) rates were 68 or 63%, respectively, while 3- or 5-year relapse-free survival (RFS) rates after CR were 60 or 43%, respectively. Although this study included elderly and excluded low-risk IPI and ALK+-ALCL patients, OS results were superiorly favourable, indicating the efficacy of this Double-CHOP regimen. However, an effective treatment strategy for refractory or relapsing patients needs to be validated and established.
Found this. "Front-line treatment of peripheral T-cell lymphomas (PTCL) involves regimens such as cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and results in a 5-year overall survival (OS) rate of less than 50%."
Valery. Learn to discriminate between the serious posters on this board and the hypers and bashers.
SPPI has a credibility problem. We are thinly traded, and controlled by the shorts. The PPS is not a reflection of what's going on within SPPI. The pipeline is completely ignored right now. All that does not mean that SPPI can't turn up in a real hurry.
If you read my posts you know I didn't expect any big jump even had Evomila been approved. It's not a game-changer.
Ouch. I find the p-1 poziotinib data to be so profound that I need to see it repeated in the phase II trial(s) to even begin to believe it. You are right that if confirmed this data could be explosive.
I wish they would tell us what's going on with SPI-1620. This could be a complete dud or it could also be explosive.
Getting close to crunch time on these two.