I actually had chance to go through "Special Call" conference, and HEPLISAV phase III trial result which is excellent; however, the safety database patient size issue requires another phase III trial to enroll around 65,000 participants, the related duration could be 6 month treatment period, plus 6 months follow up, the trial could cost range would be in 70m to 90m range, it would likely to take 3 to 4 years to complete this additional phase III trial.
With some where around 80m cash in hand, the company has to dilute its shares(double existing shares) to get funding to complete the additional trial in next 4 years or so. Therefore, a better way than do it yourself is to look for a major partner to pay trial expense and get it done more quickly
The above opinion was based on my a few hours reading, I may miss something obvious, please have your inputs
Are you saying I did right thing to purchasing 10000 shares at $11.52, 10000 shares at $11.27 and 10000 shares at $11.25?
Hopefully, it will bounce back to above $12 in a few weeks
50% upward move based on the previous day closing price.
I would predict closing price on July 27 will be $11:50 to $12.50, then after approval price could be $16 to $18.
I have no doubt that FDA has reviewed oral relistor phase III trial result when they are preparing subc relistor chronic pain indiation approval.
A bad oral relistor phase III trial result would certainly have VERY negative impact on subc relistor chronic pain indication approval because subc is fairly expensive for long term use. However, the excelent oral relistor phse III trial result removes FDA concern on subc relistor cost because oral relistor is will replace expensive subc relistor very quickly in a few years.
Just a month and half to go...
This study is supported by National Cancer Institution, and another one will be on its way to confirm the finding in this study.
FDA has one more good reason to approve SC Relistor
Background: The abundant expression of prostate specific membrane antigen (PSMA) type II transmembrane glycoprotein on prostate cancer cells provides a rationale for antibody therapy. PSMA ADC, a fully humanized antibody to PSMA linked to the potent antitubulin agent monomethyl auristatin E (MMAE), binds PSMA and is internalized within the prostate cancer cell where cleavage by lysosomal enzymes and releases free MMAE, causing cell cycle arrest and apoptosis. We report results from an ongoing phase 1 dose escalation study of PSMA ADC in subjects with taxane-refractory mCRPC. Methods: Eligibility requirements include progressive mCRPC following taxane-containing chemotherapy and ECOG status of 0 or 1. PSMA ADC was administered by IV infusion Q3W for up to 4 cycles. Adverse events, pharmacokinetics (PK), PSA, circulating tumor cells, clinical disease progression and immunogenic response to PSMA ADC were assessed. Serum PSMA ADC and total antibody were measured by ELISA, and free MMAE was measured by LC/MS/MS.The dosing cohorts range from 0.4 mg/kg to 2.8 mg/kg, with dose escalation continuing. Results: 40 subjects have been dosed in nine dose levels (0.4, 0.7, 1.1, 1.6, 1.8, 2.0, 2.2, 2.5, 2.8 mg/kg). To date, PSMA ADC has been well tolerated with the most commonly seen adverse events being anorexia and nausea, and the most common laboratory abnormalities being reversible hematologic parameters and liver function tests. Antitumor activity has been manifested as reductions either in PSA or circulating tumor cells in the higher dose cohorts. Exposure to PSMA ADC increased with dose and was ~1,000-fold greater than MMAE exposure. Similar PK metrics were observed after the first and third doses. Dosing at the 2.8 mg/kg cohort is continuing and an MTD has not yet been reached. Conclusions: PSMA ADC is generally well tolerated in subjects with mCRPC, previously treated with taxane in doses up to 2.8 mg/kg. Antitumor activity at higher dose levels has been observed. The MTD has not yet been reached and enrollment is ongoing at higher dose levels.
Oral formulation has exactly same safety profile as placebo - better than SC form.
IT IS JUST MATTER OF ANOTHER TWO MONTHS FOR APPROVAL
Oral Methylnaltrexone for the Treatment of OIC in Patients With Noncancer Pain
Results: Demographic and baseline characteristics were similar among groups. For the primary endpoint, a significantly greater proportion of subjects in the 300 and 450mg dose groups experienced RFBMs within 4h of dosing compared with PBO over the 28 days of QD dosing. These findings were maintained throughout the entire 12 weeks including QD and PRN phases. Significant differences were also seen for ≥ 3 RFBMs/week with an increase of ≥ 1/week over baseline at the 300 and 450mg doses during the 28 day QD dosing (Table 1). Analyses based on the primary endpoint demonstrated a linear dose response for the 3 active doses (p<.0001) over 28 days of QD dosing. For the first dose (Figure 1), significant differences were seen in the 150 (34%), 300 (41%) and 450mg (42%) treatment groups for RFBM by 24h post first dose compared with subjects receiving PBO (23%) (p=0.0200, p=0.0002, p<.0001, respectively). The incidence of adverse events (AE) was similar among treatment groups and PBO: most common AEs (≥ 3%) were abdominal pain (6.0% PBO, 6.8% all MNTX), nausea (5.5%, 4.7%), flatulence (4.5%, 4.0%) and diarrhea (2.0%, 3.3%).
Conclusions: Oral MNTX 150, 300 and 450mg QD significantly increased the proportion of RFBMs and decreased time to first RFBM in a dose-dependent manner in patients with OIC. Efficacy of oral MNTX in this study was comparable to that reported in clinical studies of SC MNTX in subjects with chronic, noncancer pain
The excellent oral phase III trail result is to be published this weekend, and additional data to FDA could very likely including oral phase III trial data, which has better safety profile, and will certainly help FDA to make approval decision because the oral is the one will be widely used.
I don't mind a few barking sound around here because they are doing their job to make their living. That is the way of life, and only a few NICE individuals are qualified to do so...
You should sell if you are not willing to take the risk; EVERY info you need to know are out there, the company could not give you more than it has, and it can't tell you what it does not know; it is waiting for FDA approval decision like everyone else
I could be easily doubled if approval, and it will move up from there because oral relistor approval will be sure thing and just matter of 1 year from now
After approval for the chronic indication, relistor is going to be blockbuster drug in a few(three) years
Waiting for PSMA 2.8mg group data if Q4 earning is not released in this week...