The final approval of drugs is supposed to be granted or denied based only on the products merits and per-formances in the trials. Unfortunately, management unfamiliar with the approval processes caused very promising products to fail the test for reasons mostly unrelated to the safety or efficacy of the products. This has been confirmed in several cases where the appointment of a knowledgeable specialist has been successful in getting FDA approvals for products that had been previously rejected. Most of these rejections were related to inappropriate planning or presentation. Every decision counts.
Wrong choices can cause a rejection that can harm the firms finances.
The management and . . Securing alliances has been important to the survivability of biotechs. It is imperative that the start-up biotech firm be run by persons with superior public relations skills and ongoing contacts with the responsible parties in the conventional pharmaceutical arena and financial institutions. Concluding fair and lucrative alliances with these drug firms depends, in the first place, on the value of the start-up products and technologies. Yet, the negotiator must be shrewd, know how to present the start-up case and find friends among the decision makers in the drug firms who have confidence in his opinion and credibility.