An Israeli pharmaceutical company planned an IPO and the underwriters needed a legal expert on the FDA to prepare an FDA regulatory opinion letter. In addition, underwriters’ counsel requested that AGG address compliance with all major U.S. healthcare laws.
AGG attorneys reviewed regulatory documents in an internal database and spoke with the company’s vice president of regulatory affairs and in-house counsel to ensure that AGG could attest, to the best of its knowledge, that the company was in compliance with FDA laws. AGG prepared the regulatory opinion letter, which, at the request of underwriters’ counsel, was expanded to include an opinion about the company’s compliance with all U.S. healthcare laws. The request, which went well beyond the scope of the initial request, had the potential to delay the filing and create unexpected additional expense. That scenario was avoided when the AGG team was able to explain why, in this case, why we could not provide such an opinion but could address the concerns without significant time and cost. Underwriters’ counsel dropped the request.
The Israeli pharmaceutical company announced on May 31, 2013 its initial public offering in the U.S. of 5,582,636 ordinary shares at a price to the public of $9.25 per ordinary share. Shares of the company’s common stock began trading on the NASDAQ Global Select Market. The public listing furthers the company’s mission to produce the highest quality life-saving therapeutics. In-house counsel and the CEO expressed their appreciation of AGG efforts, especially how quickly the firm handled unanticipated matters.