The FDA probably decided not to set a precedent by allowing a BTD for that indication without having the pain, bleeding, infection data even though the company was probably told they could bypass that. I say "probably" but I am pretty sure that is what happened in my opinion.
Now that the FDA has decided not to waive any detail the company can proceed forward with that detail by doing a study....simple.
Aggravating yes....but straightforward now.
Lawsuits.....more just a form of free advertising for the Law Companies and The Street. I saw nothing in there to be concerned about. They based it all upon innuendos by AF.....Yawn.....a tale told by an idiot, full of sound and fury, signifying nothing.
A cookie to the first who guesses who said that.
Timing of denial letter.....IT guys can show the email times and when it was clicked on if that was how it was sent. Registered mail shows the date and time it was signed for the hard copy. Hotel and travel times easy to track....no worries there. And even if they did hold it a day...SEC rules you may hold on to material news for four days.
Stock price....the volatility is over for now. The stocks started trading partial penny trades late afternoon indicating that the retail sellers are out. The weak hands are gone and institutional holdings are likely up.....in the long term that is better news for those still holding. I am expecting slow accumulation by hedge funds and institutions. If anybody declares a 5% stake then expect a buyout offer though poison pills are likely in place to prevent hostile takeover.
Moving forward....we have ASCO, conference call and hopefully regional deals coming up. If such a regional deal closes with large upfront money and the stock is still low then maybe we get a stock buyback to reverse much of the dilution and still have money to run the company and a full PIII if they have to go that route....though I do not expect a PIII but a bridging study instead. Denial of the BTD for now should not have an impact on foreign licensing deals since they were waiting on what a trial design or what the path should look like. That design is clear now.....so bring on the MOU's soon please.
