Suggests possible buyout....$16 target with approval sales projection of $200 million first year...but must jump through the fda hoops first....MAJOR UPSIDE POTENTIAL VS DOWNSIDE
Hmm, you were right uni about the decision coming before the JPMorgan get together - lots of wheeling and dealing done there. My fear is Lynch himself underplayed the P3 study and he will be unwilling to make amends so soon.
The FDA took full advantage of a flawed original study. However, the FDA caused part of the problem by not requiring double-reads on the CT imaging from the start. The Augment efficacy data was at the low end of being acceptable, and it seems the FDA is trying to push it over the edge by re-interpreting some of the data.
One must realize that all radiologists use different language in their interpretive reports. Therefore, double-reads will almost definitely allow the FDA to "spin" the findings in whatever direction they choose.
I think it's possible we could actually see a buyout announcement within 60 days. My thought process is that a larger company with deeper pockets will realize this product is very close to approval. They would want to buy out the company now and guide the company more quickly in getting this FDA data resubmission done right the first time (i.e., in a few months). By getting this done right the first time, the acquiring company can also preserve existing cash on hand.
I like the idea actually. If a buyout is announced, what is everyone's thoughts on the share price?
I don't see BMTI being able to get approval on their own unless they appeal. They have a great argument on appeal due to the FDA changing the protocol (primary endpoint) after the study was complete. If there was ever a reason for reversal that is it! BMTI is now playing the Cash burn game and many investors including myself do not want to wait quarter by quarter and 'hope' a buyout occurs. I will wait about 60 days to see how Canadian study goes and if we get EU approval and if we appeal FDA and announce a possible 'strategic alternative' in trying to find a partner. I was just finished with a bankrupt Biotech and saw it all the way through the end when that company (Middlebrook) had about 1.5 years of cash and no debt at the time and burnt it all up until it was too late!
I do not trust the process anymore so I will give BMTI 60 days (by end of February) and see how proactive they are. Otherwise the stock will lose about $.25 every 3 months in since it is trading based on 'cash value'.