I'm not saying you can't make money overpaying for a good science or technology - the point I'm making is that good science/technology alone doesn't make for a good investment.
And with biotech - don't kid yourself - the ebb and flow of stock price is all "hope and dreams" and "perception" of future potential. As the possibilty of success increases the value assigned to the company goes upward and vice versa. The you have to add in the "hype" factor of the current climate - biotechs ride the ebb and flow of investor sentiment - they go in and out of favor - and the valuations as a group rise and fall - just as some sectors go in and out of favor - as recently witnessed by the recent 6 month "stem cell euphoria"
To ignore investor and market sentiment - and only focus of the science is a great way to go broke pretty quickly.
Now to reply to your statement about companies with phase 3 products - when DNDN was waiting for their first FDA panel result it was $15 - $20 a share. and it sported a market cap of $1.5 billion. Being cash rich or poor has nothing to do with the valuation put on the IP. The increase at that time from a $300m market cap to nearly $2 billion has all to do with perception and the buzz. My point is that it had the same science @ $3 that it had @ $20 - so what changed? It was perception and "hope" and "expectations" - sometimes those expectations are under valued - sometimes way overvalued.
If you disagree with this then perhaps investing isn't your game and perhaps you should look at going into applied science rather then investing. For me it's not about the science - it's about the investment - the only reason I invest is to make our funds and myself money. If you really want to make a difference and cure aids/cancer - take some of the profits and donate to the MDA or some cancer insitute that funds preclinical research.
I believe that Dor Biopharma has a much better chance of exhibiting good data based on the data below, than Osiris does. Below is a Jefferies report on Osiris' in their trial
While its strong cash and GENZ partnership for the stem cell franchise are positive for OSIR shares, we continue to view its first controlled/randomized/double-blind study for Prochymal (Ph.III data for steroid-refractory GvHD in 3Q09) as highly risky. Ahead of this binary event, we view risk/reward as skewed towards downside.Ph3 steroid refractory GvHD data for Prochymal in 3Q09 is next catalyst.
Dor BioPharma has reached an agreement with Sigma Tau that gives Dorb the cash to fund the phase 3 clinical trial for the treatment of Intestinal GVHD after stem cell transplant, that can lead to an approval of orBec in the United States and Europe. Dor will receive a 35 percent royalty on net sales in the United States. DorBiopharma retains the rights to orBec in the rest of the world. In orphan diseases Europe actually allows pricing equivalent to the United States, so the European Market size is probably the same or larger than the US market.
In November the company had less than a million dollars in the bank and a drug ready for phase 3 but without the resources or an agreement with the FDA on how to proceed.
Now the company has received an SPA from the FDA to reach an endpoint of Intestinal GVHD treatment failures at eighty days post randomization vs the standard of care (high dose predisone) which is not even approved. The P value needed in this one phase 3 trial is .05. In the prior phase 3 study the company reached this endpoint with a P value of 0.005. with a smaller number of patients. In my mind this means the clinical risk is very low. The company now has the resources to get the drug approved.
The primary endpoint is the treatment failure rate at Study Day 80. This endpoint was successfully measured as a secondary endpoint (p-value = 0.005) in the previous Phase 3 study as a key measure of durability following a 50-day course of treatment with orBec® (i.e., 30 days following cessation of treatment).
Other data from the prior phase 3 trial.
orBec® did achieve statistical significance in other key secondary endpoints such as the proportion of patients free of GVHD at Day 50 (p-value 0.05) and Day 80 (p-value 0.005)
The median time to treatment failure through Day 80 (p-value 0.0226),
A 66% reduction in mortality among patients randomized to orBec® at 200 days post-transplant with only 5 patient (8%) deaths in the orBec® group compared to 16 patient (24%) deaths in the placebo group (p-value 0.0139).
At one year post randomization in the pivotal Phase 3 trial, 18 patients (29%) in the orBec® group and 28 patients (42%) in the placebo group died within one year of randomization (46% reduction in mortality, hazard ratio 0.54, 95% CI: 0.30, 0.99, p=0.04, stratified log-rank test).
DOR is currently in a clinical trial studying orBec for the prevention of GVHD in stem cell transplants by giving orBec prior to transplant. The prevention market would be two to three times the size of the treatment market. This trial is fully funded by a grant from the NIH.
The company has the go ahead from the FDA start a trial with a slightly different formulation of oral beclomethasone in the treatment of radiation enteritis. Radiation enteritis is a condition in which the lining of the bowel becomes swollen and inflamed during or after radiation therapy to the abdomen, pelvis or rectum. Most tumors in the abdomen and pelvis need large doses, and almost all patients receiving radiation to the abdomen, pelvis or rectum will show signs of acute enteritis. There are over 100,000 patients in the United States annually who receive abdominal or pelvic external beam radiation treatment for cancer who are at risk of developing acute and chronic radiation enteritis. This trial has an excellent chance of getting government funding because of the unmet medical need and fast track status it has received from the FDA.
The company is also the world leader in the Ricin Bioterror threat, and grants and additional funding is anticipated shortly
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