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Tuesday, October 31, 2017 10:32:41 AM
For example, with the benefit of hindsight, I have been critical of the decision to move forward with SOX as an IR ADF, a highly differentiated product, because it was a departure from the cost control strategy that is part and parcel to generic drug companies and is anathema to differentiation at the expense of cost. Yet, the information available to Elite at the time included the belief that the SOX Tmax would not be an issue and, since IR opioids offered a clear competitive landscape unencumbered by potential litigation from Purdue and the FDA waived the NDA fee, this made sense at the time. It seemed even more so when granted a Priority Review that offered a statistical (95%) likelihood of approval. Yet, it was not approved and I agree with you, the reaction of disbelief was not only held by shareholders but by management. At that point, I still have no truck with management and the decision it made. But, in your estimation they did not react well and without question the ability to adapt to the competitive landscape is what separates ultimately successful companies from the muddled management of the less than adaptive.
So, what should Elite have done? As they had not received a second CRL, they needed to try again to fix the Tmax. I believe we can agree it is a work in progress. But it must remain so. We are not talking about missing on a cancer cure, this is a statistical goal that scientists should be able to achieve. So, let them achieve it and those who believe they will should remain invested and those who do not or do not wish to wait should move on, as you indicated you are doing. That is the point of investment decisions that, like all decisions, are based on the best available information at the time.
Best of luck to you, my friend.
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