Your position is clear. What is negative for Spectrum is unreal. Of course, only positive deserves your attention. Ostrich approach. BTW, there are a couple of positive reviews, not like on cafepharma.
According to recent study, “the cost of research per patient on a phase IIIA oncology trial has ballooned from an average of $3,000 to $5,000 in the early 1990s to a range of $75,000 to $125,000 in 2013. In just 3 years (from 2008 to 2011), per-patient clinical trial costs increased by 70%.” (see "Impact of Cancer Research Bureaucracy on Innovation, Costs, and Patient Care" J. Clin. Oncol. 32, pp 376-378, 2014). Based on these numbers, cost of 2 X 500 patient trials with SPI-2012 will be around $100M. Add Apaziquone. Last time they run two 800-patient trials and if to assume that a new trial will require only 50% of that number, they will need to spend another $80M. Total is $180M. In 2016, prices will be much higher. Right now Spectrum has $130M in cash. How are they going to afford it? Even with stable revenue from Fusilev mission is impossible (without dilution, of course). They need to drop one of the projects.
Purpose of this study is to "determine the Maximum Tolerated Dose (MTD) for belinostat when combined with CHOP regimen and establish the recommended belinostat dose for the Phase 3 study." Future Phase 3 study is not exactly post-marketing. It is required by FDA to prove benefits of the drug using other measurements of disease. In BELIEF study, they used response rates as endpoint. Now they will need to find effect of the drug on overall survival. Remember that Belinostat was approved under accelerated approval. Therefore, Spectrum needs to continue studies to get full approval. One important point is that in their phase 3 trial, Belinostat will be used with CHOP as a first-line treatment, which would significantly increase patient population for the drug.
I do not know how significant is this trial for Spectrum. First, you have no way to establish the benefit of Marqibo, since it is present in both arms and is a part of two multi-component drug cocktails. Second, we may never know the results. Do you know the outcome from two Phase 3 studies with Marqibo in Retinoblastoma, NCT00335738 and NCT00072384, conducted by Children's Oncology Group and completed in December 2011?
Most likely, we will find it earlier. If you want to see phase 3 with similar development, check NCT00057876. Just another example.
"When people see what a clown you are" Ha, you recognized yourself as a clown in my yesterday post and got angry. Funny. I did not mean you. But you know better.
"Even though I don't like answer your useless arguments"
Who cares about what you like and what you don't like. I guess you like trees and forest. You need to learn a bit more about Spectrum before you start giving your opinions.
Look at revenue average estimate for 2015 and 2016 under Yahoo Finance. It is $162M and $161M, respectively.
"Quarterly Revenue Growth = 25%"
1stQ15 might the last quarter with growth in near future.
Of course, it is just analyst's opinion against yours.
Of course, you not agree.
Everything depends on Fusilev. Even Raj does not know what will happen with Fusilev's revenue in next quarter. Uncertainty is not helping.
"Antitumor Activity of HM781-36B, alone or in Combination with Chemotherapeutic Agents, in Colorectal Cancer Cells"
Drug is a potent inhibitor of growth of CRC cells overexpressing EGFR. Additive or synergistic effect was observed when Poziotinib was used in combination with chemotherapeutic agents. Good starting point.
Raj said that approval process will include ODAC meeting. He also said that FDA expects that majority of patients should be recruited at the moment of the meeting. Recruitment to the two previous Apaziquone studies took around 2.5 years and was done with substantial help from Allergan. It seems like best case scenario is that ODAC meeting could be held at the end of 2017-early 2018 if they start enrollment in the middle of 2015. Not very encouraging. Right now, they need to be more focused on starting enrollment than on filing an NDA.
Many Spectrum’s trials have status “Active, not recruiting patients”. My thought was that it means that enrollment target is reached and most time-consuming and expensive part of the study is behind. If true, it means that company reached a real milestone and should issue an announcement. In the past, Spectrum announced completion of enrollment for several trials including Apaziquone single instillation phase 3 study (Jan 12, 2010), Belinostat in PTCL and CUP studies (Sep. 2011 and Dec. 2010), and CE-Melphalan phase 2 study (Oct. 2013). Based on this pattern, we can conclude that other trials with status “Active, not recruiting patients” for which announcement has not been made, did not reach their enrollment target. Therefore, Apaziquone multi-instillation trial, Marqibo in ALL, SPI-1620 in NSCLC and many other studies are under enrolled for some reason and no good results should be expected.
Submitting pooled data from two failed studies and getting approval could be unprecedented in FDA history. At least, I could not find any example for that. Think about it. One study failed. Then another one. What Raj is trying to sell to FDA is post hoc analysis, looking at the data—after the experiment has concluded—for patterns that were not specified a priori. It is called data dredging. Many companies with failed phase 3 studies do post hoc analysis but to prove that drug works they must run another trial and get results before NDA submission. Why other failed companies do not follow the path that Spectrum is going to follow? I would not listen to what Raj says. He desperately wants Apaziquone approval. Most likely, his team met with FDA on Apaziquone many times but could not get a clear answer.
"If they were experts at running something as complex as a biotech company they world be a biotech company." If they can make more money by being a hedge fund, why would they want to be a biotech company? Their job is making good investments. What they see is that company they invested in has a CEO which is incapable of running and presenting the business. Raj lacks integrity. Spectrum is in biotech sector, has a decent revenue but is valued as a generic company. And it is a CEO's fault. Something needs to be done.
"It's not significant anymore since they revised (corrected) the protocol in early March to indicate Marqibo is NOT being used"
I can see it now. First, they corrected description of the trial on 06-11-2013, replacing doxorubicin with Marqibo. Screw up from Children's Oncology Group.
Problem is that we do not know whether they recruited all patients in multi-instillation trial or they simply stopped recruitment after the results from single-instillation trial were disclosed and just before Allergan decision to bail out. I think they enrolled only a few patients in this trial and are following them. It is a logical explanation to why spending on two 658-patient Phase 3 trials in last two years was just $1M-$1.5M/year.
If CE-Melphalan indeed reduces the incidence of grade 3/4 mucositis, it is a substantial advantage. Doctors will find it out shortly.