Post by rob37 on Apr 7, 2014 10:00:53 GMT -5
Did you listen or follow the FDA Adcom? If you did, you would know that.......
If you followed the adcom closely like I know many of you did
you would absolutely know that a delay was inevitable. Why? Because the FDA wants to reject? NO. Because the panelist had a lot of suggestions on how to move forward WHEN the drug is approved. There will be labeling issues to work out. There will be post marketing studies to define which at this point is becoming the norm (thank the heavens). And, I would like to think that most if not everyone invested in a pharma knows that the FDA does not move quickly. There was NO WAY they were going to draft a simple letter saying "approved" in two weeks between the adcom and PDUFA date. A delay from the FDA was guaranteed.
The question you have to ask now is what do you expect going forward. This is what I expect and I'm no fantasy in investor:
1. FDA will approve in 3 months.
2. Approval will include post marketing requirements.
3. MNKD will secure a partner to agree to sell the company.
As far as the logistics and details like more dilution and what labeling requirements - WHO KNOWS. What I do know is this - Alfred is NOT going to let his baby die at this point a terrible death. He's put an amazing amount of money on the line funding this and he's at the 1 yard line. If, by chance, your stomach is now sour and you can't sleep over the stock price movements, I suggest selling and moving on. Go buy GE. But if you want to take the financial ride of a lifetime with a "happy ending", then pull yourself together and stop watching the daily swings. This party is just getting warmed up. I can't wait!!!
If you followed the adcom closely like I know many of you did
you would absolutely know that a delay was inevitable. Why? Because the FDA wants to reject? NO. Because the panelist had a lot of suggestions on how to move forward WHEN the drug is approved. There will be labeling issues to work out. There will be post marketing studies to define which at this point is becoming the norm (thank the heavens). And, I would like to think that most if not everyone invested in a pharma knows that the FDA does not move quickly. There was NO WAY they were going to draft a simple letter saying "approved" in two weeks between the adcom and PDUFA date. A delay from the FDA was guaranteed.The question you have to ask now is what do you expect going forward. This is what I expect and I'm no fantasy in investor:
1. FDA will approve in 3 months.
2. Approval will include post marketing requirements.
3. MNKD will secure a partner to agree to sell the company.
As far as the logistics and details like more dilution and what labeling requirements - WHO KNOWS. What I do know is this - Alfred is NOT going to let his baby die at this point a terrible death. He's put an amazing amount of money on the line funding this and he's at the 1 yard line. If, by chance, your stomach is now sour and you can't sleep over the stock price movements, I suggest selling and moving on. Go buy GE. But if you want to take the financial ride of a lifetime with a "happy ending", then pull yourself together and stop watching the daily swings. This party is just getting warmed up. I can't wait!!!