I'm just wondering if those of you more familiar with how clinical trials work can let me know if you believe the CEO when he says he doesn't have any idea what the phase 2 VGX trial results will look like because it's still blinded? Based on my research, spontaneous regression of high grade CIN is very rare. As such, even blinded, if you see any regressions in the entire population what so ever beyond the normal few percent that are expected, you could accurately assume the vector works no? If you don't see any increase then blinded or not, it doesn't work. So blinded or not, the researchers at this point must have a pretty good idea what the results will look like. And I find it hard to believe the CEO isn't asking the trial conductors what they are seeing.
I bought INO at around 50 cents and sold at a dollar. Been kicking myself for selling during the first run. Thinking of getting back in. But the above mixed with the fact that they didn't wait for the results to raise capital has me thinking that the CEO may know something we don't and wanted the company to be financially ready for bad news.
Any thoughts? Are the doctors sworn to complete secrecy or something? I'm rooting for this one because I've already made some money with it and this could save a lot of lives. I don't want to get burned though like I did with adxs...
Clinical trial data is confidential between the Sponsor and the FDA or EMEA until the regulatory agency completes a review and gives a confidential response back to the Sponsor. The Sponsor, in turn, makes a public announcement about good news, comments about any new information that is required that would lead to a positive review in the future, or if it is bad news, the Sponsor terminates the trial or redesigns a trial which leads to a delay. The good news about biologics that represent vaccines . . . like the potential product . . . the reviews are usually all or none. Inovio has so many biologics in their pipeline and strong scientific collaborations that are medically important for humans that it is hard to believe that they will not be successful with several in the next two years. I bought in in March 2013 knowing that it would be 3 years to any significant regulatory interactions and BLAs. Forty-three years of helping physicians get to clinical trials. They are on target to make my investment worth while.
Sentiment: Strong Buy
Where did you do your research?
Type this in your search browser:
Spontaneous Regression of High-Grade Cervical Dysplasia: Effects of Human Papillomavirus Type and HLA Phenotype
An article in Clinical Cancer Research should come up.
Here's an excerpt:
"Persistent infection with a high risk, or oncogenic type of human papillomavirus (HPV) is necessary but not sufficient for the development of most squamous carcinomas of the cervix and their precursor lesions, cervical intraepithelial neoplasia (CIN; ref. 1). CIN1, CIN2, and CIN3 lesions represent a spectrum of disease. Low-grade, or CIN1 lesions, represent a chronic HPV infection, in which HPV DNA is episomal and intact virion production and shedding occur. In women who are immunocompetent, many low-grade, or CIN1 lesions, will nonetheless eventually regress without intervention (1, 2). Reported rates of regression range up to 58% over 24 months (3). A very small percentage (∼2%) will progress to high-grade lesions.
Experimental Design: Our study cohort included healthy women with high-grade cervical lesions (CIN2/3) with residual visible lesions after colposcopically directed biopsy. We prospectively followed 100 women over 15 weeks before standard resection. HPV typing was done using PCR and a reverse line blot detection method.
Results: The rate of spontaneous histologic regression, defined as (CIN1 or less at resection) was 28%."
Generally, think of it as 1/3 of high risk lesions per year progress, 1/3 stay the same, and 1/3 regress. The longer it does not go away, the longer the likelihood of progression to cancer or from CIN2 to CIN3.
And there would be no way to know who got the study drug in a blinded trial, especially one where ~1/3 of the lesions get better on their own without treatment.
CIN II/III has different regression rates than CIN I. I believe the trial CIN II/II? Furthermore, hpv 16 cause CIN II/III regression rates are even lower (this trial I believe focuses on 16/18)
"In the study window of observation, spontaneous regression occurred in 9 of 44 (20.5%) of those women with single infection with HPV16 (Table 3). In contrast, in women infected with types other than type 16, the rate of spontaneous regression was 12 of 33 (36.4%). "
In the call I just listened to, DR Kin expects a 25% regression rate in his controls.
Admittedly, this is higher than I thought. My research is a few years old (from when I was an investor of ADXS)
I'm undecided on whether it is advantageous to raise capital before or after positive results. The low hanging fruit is that it's more advantageous to raise capital after positive results so there is less dilution. Stepping back a bit and looking at the bigger picture I can see a scenario where raising capital after positive results is more advantageous.
PPS is more resilient with a catalyst coming as compared to a catalysis already gone by. For example, we raised capital at sub $3 and we've easily recovered since. In contrast, raising capital post positive-catalyst can be a huge momentum killer as it gives investors incentive to take profits and sit on the sidelines to wait for the offering volatility to pass. Further, we are still expecting a number of catalysts this year and there's something to be said about stringing a number of catalysts together as compared to interrupting them with a dilution. (See e.g., INO July 2013).
My point is that given a time frame of a year, there's a colorable argument that raising money before the VGX-3100 results will result in a higher market cap than raising it after. With that said, I'm not speculating that Kim has this play in mind, I think he's just doing what he said he was doing, which is being prudent and raising money when he doesn't need it.
fathead, just because an intelligent post questions the foresight of the company doesn't mean it is worthy of a "sounded negative". I give the OP thumbs up for raising the issue that you apparently don't want to... or can't.
Sentiment: Strong Buy
Not possible. Three parhologists analyze each sample. None of them know which patient the sample is from. No history or ID associated with any sample, just a slice of tissue under a microscope.
I think the op also implies the clinical doctor will notice results before the company. I think that may open the window for the clinical doctor to buy INO stock. Is that legal or not? I don't know. Anyone know if it is OK for a clinical doctor of a drug study to buy stock of the company?
Just my opinion mind you. INO did just rent a new building, they are setting up to start Phase lll testing, Dr. Kim's words and besides, INO knows or Their results & findings w/ Ph lll. That's what has them setting up fro Phase lll
I guess you don't think that it would be irresponsible, in light of the P1 trial, to be set up and ready to go on P3. Me? I wouldn't think much of Kim if he wasn't getting ready, and I do think enough of him to think that he wouldn't risk everything by trying to get the results early and act on them. I think Kim does everything 'by the book'. To suggest otherwise, I think, is insulting to Kim and every investor that's here because we believe in him.
Sentiment: Strong Buy
I don't have any idea on how blind studies work either, but as for the capital raise at this point based on knowing something negative is likely not the case. I think they were advised to take advantage of the current market conditions and high interest in the stock. Nothing more and nothing less.
I do not believe there is a chance that the answer has been revealed yet. The uptick is part of the guessing game that goes with this kind of stock before results are published. Couple that with a few interesting internet posting from a few so called and self proclaimed experts this it goes up a little. This will happen a few more times before we get the results. I would not frown on it I would enjoy the enthusiasm. Cheers and Good Things
Sentiment: Strong Buy