Investor sentiment is negative. Several reasons for the negative performance of the stock. Issuance of a CRL is bad news. Class 2 submission means FDA decision is several months down the road. Cash position of the company is poor. The company's future is highly dependent on this outcome. Approval chances for Illuvien are not as optimistic. The volume and stock price indicate the bad feeling. Uncertainty is the kiss of death for stocks. Investors are getting bored and looking elsewhere. Dead money for months.
Bite Me, off topic question, MELA hears from FDA tomorrow. Take a quick look. It is a software melanoma detector that had a lot of hype and was in the low teens, then FDA delayed decision and she slowly has made way to $3-4. From what you know is MELA a buy today for FDA approval tomorrow. Thanks, CBall
Most professional traders who are experts in life science/health care field buy these stocks prior to PDUFA. We seldom hold past that date and only if we see an estimated 80% chance of approval. We believe it is better in the long run to avoid placing our fate in FDA hands. This is simply a general opinion and doesn't hold true in all cases, but a good guideline to follow. Good luck
i am not sure exactly what will happen but i know people who either work for the company or are in the hopper to be hired. they are still optimistic. late last year they hired some higher ups based on approval. the delay wasnt expected but the data still looks good. with the fda you never know but there doesnt seem to be any reason for this not to get approved. it has efficacy vs the standard of care treatment, showed decent safety, and got priority review. i think they will resubmit late first quarter and are hoping for third quarter launch.
any thoughts. getting tired of being wrong but in this case i actually have a little info.
I completely agree. There is no reason for the FDA to reject this drug. It performed beyond their expectations and trial requirements.
The cataracts were a minor issue and in the trial those patients who had already had cataract surgery had results exactly like those who had not after the cataracts were removed. The FDA simply wanted to confirm that the cataracts were not a factor in any of the results.
The 36 month data and the trial that did not make statistical significance at 36 months was not a surprise. The steroid from the device diminishes and the placebo group continues to get standard of care treatment which includes very expensive therapies every month.
The bottom line is this...With one injection this company provided 33 months of safe therapy that was TWICE as effective as the best thing standard of care could deliver.
This drug will get approved and PDQ. I believe Credit Suisse estimates of 800 mil in sales in 5 years. Looking at the low cost dynamics of selling to only 1600 retina specialists I see potential EPS that could justify an $80-100 stock price.