1) With closure of two trials begun just a few months ago, cost burn now greatly reduced.
2) BARDA smallpox contract that can net up to 435 million over 5 years. Currently the contract is worth 100 million dollars for 60 months.
3) The drug works to prevent CMV infections, and with 92% confidence works against BK virus infections -- see page 38 of the Feb 22 slides.
4) There is no extreme diarrhea toxicity under lower doses: the P3 overall diarrhea incidence level is actually significantly smaller, on a per-week basis, than the P2 diarrhea incidence level. The amount of diarrhea is greatly reduced under the P3 versus the P2 when the patient is treated under the safety monitoring and management plan (SMMP).
5) The FDA will likely approve the drug for a subset of the population that had no confusion with GVHD versus diarrhea -- T-cell depleted transplant patients and higher-risk patients. There is no reason not to approve the drug.
6) As of the end of Q3 2015, the company had 378m in cash or cash-equivalent assets -- that is $8.20. Total assets equaled $391.5m.
7) In event of a sale, the company, as of the end of Q3 2015 has 301.6m in retained earning tax write-offs for the acquirer.
8) The earnings report and CC will clarify the path forward, which in my opinion is likely an NDA for a subset of the population, or a sale of the company/assets.
Once they reach 70 events, will they state how many events were in the control/drug arm and how many were in the other arm?
Secondary = follow-on offering.
Bagholders = traders/investors who bought shares and are sitting at a loss.
How are you seeing this happen? They aren't going to even state which arms the events came off of as far as I understand.
What a dumb comment, even for you, gavinnick. Most biotechs are down big because VRX's stock price imploded.
Interesting thoughts and very possible here.
Sorry for hijacking the ideas presented here, but, when do you think the safety review could be completed?
1) The platform can be used for 60 other indications. It is valuable.
2) FDA rarely changes their minds on anything due to the way that they do these reviews. It's based on consensus, so one individual cannot change the group consensus without serious backlash.
3) The company, at current cash burn, has enough cash for 1.5 years. The best-case scenario is that the FDA allows accelerated approval based on an unmet medical need (since a large number of acromegaly sufferers go untreated), or that the FDA decision for an extra P3 trial is reversed within 1-4 months.
If FDA does not budge, the best thing the company can do is to cut all of its sales staff, which is most of the company, and reduce its executive head count and salaries. That way its cash burn will be closer to $20m a year instead of $86m. At 20m, cash runway will be 6-7 years.
Worst case is that the company cuts staff, but not enough, and dilutes in a year.
4) The EU (EMA) trial, which started a month ago, needs to be either modified or the FDA demands need to be modified, because FDA wants a double-blind trial (dubiously ethical), and the EMA trial is open-label. The EMA trial was scheduled to complete in 2018 with the EMA review process completing in late 2018. However, they will likely shorten it by several months (if not a year) to reduce cash burn, and likely reduce the number of patients enrolled to 100 instead of 150.
I think the most likely scenario is that the FDA will not budge and the company will downsize to a 35m/year cash burn, likely keeping most execs and their high salaries. It's not something I want but it will still raise the price because right now the price is pressured by extreme uncertainty.
Don't forget the manipulation part. Short hedge funds can turn around a successful trial and make it look like a failure with well-established disinformation campaigns. Watch out, and don't go on any significant amount of margin.
Bilions of dollars in yearly revenues after it is approved in a few years. That's the value.
It does not mean bankruptcy. Read the 8-K:
"Under the various indentures governing the Company’s outstanding notes, if the Company does not file the Form 10-K by March 15, 2016, the Company will be in breach of the reporting covenant in the indentures and the trustee or holders of at least 25% of any series of notes may deliver a notice of default. The Company then would have 60 days from the date of receipt of a notice of default to file the Form 10-K and thereby cure the default. If the Company does not cure the default by the end of the 60-day period, the notes may be accelerated by the trustee or holders of at least 25% of the series of notes that provided the notice of default. The acceleration of one series of notes could result in a cross acceleration to other outstanding series of notes."
"The occurrence of a default under the notes would result in a cross default under the Company’s bank credit agreement. The banks would be able to accelerate the loans under the credit agreement as a result of this default only in the event the Company does not file the Form 10-K before the 60-day cure period described above expires. In addition, if the Company does not file the Form 10-K by March 30, 2016, a default will occur under the Company’s bank credit agreement. The Company then would have 30 days to cure the default. The banks would be able to accelerate the loans under the credit agreement as a result of this default only in the event the Company does not file the Form 10-K before the 30-day cure period expires. During the pendency of a default under the credit agreement (including a cross-default stemming from a breach of the reporting covenant in the note indentures caused by the Company’s failure to file the Form 10-K by March 15, 2016), the Company would not be able to draw on the revolver."
lmao, I hope you're joking... how could they have met the primary endpoint when we already knew they wouldn't meet it? The results were fabulous.